This page covers seventeen conditions and answers the cross-condition questions that individual condition articles cannot. If you have arrived here from a search like "what conditions does psychedelic therapy treat" or "is psychedelic-assisted therapy appropriate for my situation," the goal is to give you a Canadian-specific, evidence-anchored answer in one place — and to be honest about the conditions where psychedelic-assisted therapy is not appropriate. Each condition section ends with a link to the deep-dive article for that condition, where the evidence, safety considerations, and Canadian access realities are walked through in detail.
We have organised this hub the way clinical decision-making actually works: first by what's regulated and approved, then by condition family (mood, anxiety, trauma, addiction, chronic pain, end-of-life distress, eating disorders, comorbidity), then by the conditions where we deliberately recommend caution or contraindication. The substance-availability matrix below is the single most important section if you're trying to figure out what's even on the table for your condition.
Key takeaways
- Only one psychedelic-assisted therapy is Health Canada-approved: esketamine nasal spray (Spravato), and only for treatment-resistant depression (TRD) in adults 18–64. Spravato is not approved for PTSD (post-traumatic stress disorder), anxiety disorders, OCD (obsessive-compulsive disorder), eating disorders, chronic pain, postpartum depression, or any other condition.
- Ketamine is approved by Health Canada as an anaesthetic. Use for PTSD, depression, anxiety, and chronic pain is off-label. Off-label prescribing is legal in Canada when supported by clinical evidence and standard prescribing principles.
- Psilocybin and MDMA are accessed only through Health Canada's Special Access Program (SAP). They are CDSA (Controlled Drugs and Substances Act)-controlled substances (Schedule III and Schedule I respectively). The January 5, 2022 SAP amendment made case-by-case requests possible for serious or life-threatening conditions when conventional treatments have failed.
- MDMA-assisted therapy is investigational for PTSD only, not for depression, addiction, or other conditions outside research protocols.
- Schizophrenia, schizoaffective disorder, and a personal or first-degree family history of primary psychotic disorder are standard exclusion criteria across virtually every published psychedelic-assisted therapy randomised controlled trial. This is the clearest near-absolute contraindication.
- Bipolar disorder, pregnancy / postpartum / breastfeeding, and active eating-disorder medical instability require specialised evaluation and are typically excluded from RCT populations.
- Decisions are individualised. Past treatments, medical comorbidity, current medications, suicidality context, family history, cost, and provincial / private-insurance pathway availability all factor in.
What this hub covers (and what it doesn't)
This page is a navigation and decision-support hub, not a substitute for a clinical assessment. Each of the seventeen condition spokes linked below contains the detailed evidence base, safety considerations, dosing-level discussion, and provincial pathway specifics for that condition. The hub itself focuses on the cross-condition questions: how regulatory status differs across substances and indications; how to read the evidence trichotomy of Health Canada-approved, off-label, and SAP-investigational; how decisions get made when more than one condition is present; and where the safety boundaries are.
This page is also explicit about what psychedelic-assisted therapy is not. It is not a cure. It is not appropriate for everyone. Response rates in well-conducted trials are partial, not universal — and the published trial populations are often narrower than the patients who present in clinic. Comprehensive screening is a non-negotiable input, not a hurdle to clear.
The hub does not list testimonials, does not promise specific outcomes, and does not use language like cure, heal, or transform. That is by design and by ATMA CENA's compliance posture for a Canadian YMYL site under CRPO, CAP, CPSA, CPSM, CPSO, and OPQ standards.
Substance-availability matrix at a glance
The table below summarises which substances are appropriate to consider for which condition families, with the regulatory framing made explicit.
| Condition family | Spravato (esketamine) | Off-label ketamine (IV / IM / SL / oral) | Psilocybin (SAP, investigational) | MDMA (SAP, investigational) |
|---|---|---|---|---|
| Treatment-resistant depression (TRD) | Health Canada approved (adults 18–64; with SSRI/SNRI) | Strong RCT evidence (Anand 2023 ELEKT-D; Wajs 2020) | Investigational (Goodwin 2022 NEJM) | Not indicated |
| Major depression (non-TRD) | Not indicated | Off-label, evidence growing | Investigational (Carhart-Harris 2021 NEJM) | Not indicated |
| PTSD | Not indicated | Off-label, growing real-world use | Emerging | Investigational — most-evidenced indication (Mitchell 2021/2023) |
| Anxiety disorders (GAD, social, specific) | Not indicated | Off-label for treatment-resistant cases | Investigational (cancer-related anxiety strongest) | Not indicated |
| OCD | Not indicated | Off-label, small RCT base (Rodriguez 2013) | Investigational (Moreno 2006) | Not indicated |
| Panic disorder | Not indicated | Off-label, very limited evidence | Not indicated | Not indicated |
| Substance use disorders (alcohol, cocaine, tobacco) | Not indicated | Off-label | Investigational (Bogenschutz 2022 AUD) | Emerging |
| End-of-life distress (cancer) | Not indicated | Off-label | Investigational — primary indication (Griffiths/Ross 2016) | Not indicated |
| Chronic pain (CRPS [complex regional pain syndrome], fibromyalgia, neuropathic) | Not indicated | Off-label, RCT evidence (Sigtermans 2009; Schwartzman 2009) | Investigational (cluster headache pilots) | Not indicated |
| Bipolar depression | Excluded from label | Off-label evidence (Diazgranados 2010; Zarate 2012) — mood-stabilizer coordination required | Typically excluded from RCTs | Typically excluded from RCTs |
| Eating disorders (anorexia, bulimia, BED) | Not indicated | Off-label for ED-comorbid TRD/anxiety | Investigational (Peck 2023 AN feasibility) | Emerging |
| Postpartum depression | Postpartum population not specifically labeled; lactation caution | Very limited PPD evidence; lactation pharmacokinetics relevant | Pregnant/postpartum/breastfeeding excluded from RCTs | Pregnant/postpartum/breastfeeding excluded from RCTs |
| Personality disorders (BPD) | PD typically excluded | Off-label for BPD-comorbid TRD; PD primary indication not RCT-validated | PD typically excluded | Emerging signal for comorbid PTSD+BPD |
| Suicidality (acute) | FDA expanded label; Health Canada label review for MDD with acute SI | Off-label rapid-acting evidence (Wilkinson 2018) | Acute SI typically excluded from RCTs | Acute SI excluded from MAPP1/MAPP2 |
| Sleep / primary insomnia | Not indicated | Not a sleep medication | Not a sleep medication | Not a sleep medication |
| Schizophrenia / psychotic disorders | Contraindicated | Significant caution / typical exclusion | Near-absolute exclusion | Near-absolute exclusion |
Reading the matrix. "Health Canada approved" means the substance has a labelled indication under a Notice of Compliance and product monograph. "Off-label" means the substance is approved for a different indication (for ketamine, anaesthesia) but is used by a prescriber for a non-labelled indication based on clinical judgment and evidence — this is legal in Canada under standard off-label prescribing principles. "SAP investigational" means access is granted on a case-by-case basis through Health Canada's Special Access Program for serious or life-threatening conditions where conventional treatments have failed, are unsuitable, or are unavailable.
For a substance-first deep dive, see the ketamine therapy guide, the psilocybin therapy guide, and the MDMA-assisted therapy guide.
Mood disorders
Mood disorders — major depressive disorder, treatment-resistant depression, bipolar I and II, postpartum depression, and the suicidality that can accompany any of them — are the most-evidenced indication family for psychedelic-assisted therapy, and the only family where Health Canada approval (Spravato for TRD) currently exists.
Treatment-resistant depression
TRD is when major depression has failed to respond to at least two antidepressant trials from different classes at adequate dose and duration; roughly 30% of MDD patients meet TRD criteria. Spravato (esketamine) is Health Canada-approved for adults 18–64 with TRD with an SSRI or SNRI; off-label IV/IM/SL/oral ketamine has substantial RCT support (Anand 2023 ELEKT-D non-inferior to ECT); psilocybin under SAP is investigational with Goodwin 2022 COMP001 NEJM as the pivotal phase 2 evidence and MAGNUS phase 3 ongoing. See the full treatment-resistant depression article.
Bipolar disorder — safety considerations
Bipolar disorder affects roughly 2.6% of Canadian adults lifetime. Mania-induction risk is the central safety consideration, and mood-stabilizer coordination is non-negotiable. Off-label ketamine has the strongest published bipolar-depression evidence (Diazgranados 2010; Zarate 2012); Spravato is approved for TRD with explicit bipolar exclusion; psilocybin and MDMA RCTs typically exclude bipolar patients. See the bipolar disorder safety considerations article.
Postpartum depression
First-line treatments — psychotherapy (CBT, IPT), sertraline as the lactation-friendly antidepressant, and emerging neurosteroid options — are foundational. Brexanolone and zuranolone are not Health Canada-approved, though the U.S. FDA has approved both. Spravato is not specifically labelled for postpartum populations and carries lactation caution. Off-label ketamine evidence in PPD is very limited; psilocybin and MDMA RCTs typically exclude pregnant, postpartum, and breastfeeding participants. See the postpartum depression article.
Suicidality — safety-first
If you or someone you know is in crisis, help is available right now. 9-8-8 Suicide Crisis Helpline (Canada) — call or text 9-8-8, 24/7, bilingual. Talk Suicide Canada — 1-833-456-4566. In Quebec, 1-866-APPELLE. Psychedelic-assisted therapy is not a substitute for acute crisis care. Ketamine and Spravato have the strongest rapid-acting SI-reduction evidence (Wilkinson 2018; Canuso 2018); psilocybin and MDMA RCTs typically exclude acute suicidal ideation. See the suicidality article.
Anxiety, OCD, and panic
Anxiety disorders affect roughly 1 in 4 Canadians at some point in life. The evidence for psychedelic-assisted therapy in anxiety is narrower than in TRD, and Spravato is not approved for any anxiety disorder, OCD, or panic disorder. Be cautious of providers who imply otherwise.
Anxiety disorders
The strongest published anxiety-specific evidence is for psilocybin in cancer-related anxiety and depression (Griffiths 2016 and Ross 2016, same December 2016 Journal of Psychopharmacology issue). Off-label ketamine has emerging evidence for treatment-resistant anxiety; GAD, social anxiety, and specific phobias have a thinner base. See the anxiety disorders article.
Obsessive-compulsive disorder
OCD affects 1–3% of Canadians and is now classified in DSM-5 within Obsessive-Compulsive and Related Disorders, distinct from the anxiety disorders. Exposure and Response Prevention (ERP) plus higher-dose SSRIs remain foundational; the psychedelic evidence is preliminary, with Moreno 2006 (psilocybin in 9 OCD patients) and Rodriguez 2013 (ketamine RCT) as the small-N pivotal studies. See the OCD deep-dive article.
Panic disorder
First-line treatments — panic-specific CBT and SSRIs — are well-supported and should generally be tried first. The psychedelic-assisted therapy evidence for panic as a primary indication is thin, and panic patients require careful screening because the dosing experience can resemble or trigger panic features. See the panic disorder article.
Trauma and PTSD
Canadian adult PTSD lifetime prevalence is approximately 9.2% (2.4% past-year). Specific populations — Canadian Armed Forces veterans (~11.1% in regular force), first responders, nurses, corrections officers, survivors of intimate partner violence, refugees — carry substantially higher rates.
PTSD
MDMA-assisted therapy is the most-evidenced psychedelic-assisted therapy for PTSD, with Mitchell 2021 (MAPP1) and Mitchell 2023 (MAPP2) phase 3 trials in Nature Medicine demonstrating substantial symptom reduction. Access in Canada is investigational under SAP — not Health Canada-approved. The U.S. FDA Complete Response Letter on Lykos Therapeutics' MDMA-AT NDA (August 2024) has implications for the Canadian regulatory trajectory. Off-label ketamine has substantial real-world use, particularly via VAC pathways and provincial first-responder workers' compensation. Mithoefer 2018 Lancet Psychiatry documents MDMA-AT in veterans, firefighters, and police. See the PTSD article.
Burnout and moral injury — healthcare workers, military, first responders
Burnout (WHO ICD-11) is chronic workplace stress that has not been successfully managed; moral injury (Litz 2009) is the lasting impact of perpetrating, failing to prevent, or witnessing acts that transgress one's moral beliefs. The COVID-19 pandemic dramatically elevated both. For the population-specific evidence and VAC, PSHCP, and WSIB pathways, see the burnout and moral injury article.
Substance use disorders and addiction
Substance use disorders affect roughly 1 in 5 Canadians lifetime, and Canada is in an ongoing opioid-toxicity crisis. Standard-of-care addiction treatment — opioid agonist therapy for OUD; naltrexone, acamprosate, disulfiram for AUD; varenicline and NRT for tobacco; CBT, contingency management; 12-step — is foundational and is not replaced by psychedelic-assisted therapy. This matters most for opioid use disorder, where evidence-based agonist therapy is life-saving.
The strongest addiction-specific psychedelic evidence is psilocybin for alcohol use disorder — Bogenschutz 2022 JAMA Psychiatry phase 2 RCT demonstrated significant reductions in heavy drinking days versus active placebo. Ketamine for AUD and cocaine use disorder has growing real-world use; MDMA-AT for AUD has a smaller emerging signal. All psilocybin and MDMA access in Canada is via SAP. See the addiction article.
Chronic pain
Chronic pain affects roughly 1 in 5 Canadians. Syndromes include CRPS, fibromyalgia, neuropathic pain, chronic low back pain, chronic migraine and cluster headache, chronic pelvic pain, and chronic post-surgical pain.
Off-label ketamine has substantial RCT evidence in CRPS and neuropathic pain (Sigtermans 2009; Schwartzman 2009 — both in Pain). Psilocybin is investigational and emerging in cluster headache based on small pilots. Spravato is not approved for chronic pain, and MDMA is not chronic-pain-indicated. WSIB (Ontario's Workplace Safety and Insurance Board) Ontario's Chronic Pain Disability formulary covers ketamine for compensable chronic pain; VAC (Veterans Affairs Canada) mental-health benefits cover ketamine for service-related chronic pain. Multidisciplinary pain management — physiotherapy, CBT for pain, gabapentinoids, SNRIs, opioids selectively, interventional procedures — remains foundational. See the chronic pain article.
End-of-life and palliative distress
End-of-life distress — demoralization, existential dread, anticipatory grief, depression, anxiety, loss of meaning — affects a substantial fraction of patients with advanced cancer and other serious illnesses, and is a primary indication for palliative-care integration.
Psilocybin-assisted therapy under Health Canada's Special Access Program is the most clinically established psychedelic pathway for end-of-life distress in Canada — it is the indication where SAP requests are most readily granted. The Griffiths 2016 (Johns Hopkins) and Ross 2016 (NYU) trials in Journal of Psychopharmacology remain the strongest evidence base. Quebec's RAMQ has a public-funding precedent (the Farzin and Stephan SAP-approved psilocybin patients, December 2022). Standard palliative interventions — palliative-care consultation, dignity therapy (Chochinov), meaning-centered psychotherapy (Breitbart), antidepressants, anxiolytics — remain foundational. See the end-of-life distress article.
Eating disorders
Eating disorders — anorexia nervosa, bulimia nervosa, binge eating disorder, ARFID, OSFED — affect roughly 2.7% of Canadians lifetime, with higher prevalence in adolescent and young-adult women. Anorexia nervosa has the highest mortality rate of any psychiatric disorder. Comprehensive ED treatment — specialised inpatient/residential/intensive outpatient programs, family-based therapy (Maudsley) for adolescent AN, CBT-E for BN/BED, DBT, medical stabilization, nutritional rehabilitation — is foundational and non-negotiable. No psychedelic-assisted therapy is approved for eating disorders.
The strongest emerging evidence is psilocybin for anorexia nervosa — Peck 2023 Nature Medicine (UC San Diego phase 1 open-label feasibility, 10 adult female participants), with Compass Pathways COMP360-AN ongoing. MDMA-AT has a smaller emerging signal; off-label ketamine has ED-comorbidity uses for depression and anxiety. Active medical instability (low BMI, electrolyte disturbance, cardiac risk) is a near-absolute contraindication until stabilised. See the eating disorders article.
Concurrent / dual-diagnosis presentations
Concurrent disorders (the Canadian term; equivalent to dual diagnosis in U.S. literature) describe a patient with both a mental-health disorder and a substance-use disorder, though the term is also used more broadly for any clinically significant comorbidity. Concurrent disorders are the rule, not the exception — roughly 50–80% of patients in addiction treatment have comorbid mental illness, and roughly 50% of patients with severe mental illness have comorbid SUD (CCSA; CRISM).
Concurrent disorders
Integrated care — concurrent treatment of both conditions by a coordinated team — is the standard-of-care framework. Sequencing and substance-specific evidence across TRD+SUD, PTSD+SUD, ED+TRD, anxiety+depression are detailed in the concurrent disorders article.
Personality disorders
Borderline personality disorder is the PD where the psychedelic literature is deliberately cautious. Foundational treatments remain DBT, MBT, TFP, and schema therapy; most psychedelic RCTs explicitly exclude PD primary patients; emerging signal exists for MDMA-AT in comorbid PTSD with BPD features; off-label ketamine has limited real-world use for BPD with comorbid TRD. Comprehensive PD assessment, suicidality risk management, and coordination with foundational PD treatments are non-negotiable. See the personality disorders article.
When psychedelic-assisted therapy is generally contraindicated
This section is the part of the hub that most marketing-driven psychedelic-clinic websites omit, and it is the part that most clinically warrants emphasis.
Schizophrenia and psychotic disorders
Schizophrenia and primary psychotic disorders affect approximately 1% of Canadians lifetime and are the single clearest near-absolute contraindication to most forms of psychedelic-assisted therapy as currently studied. A personal or first-degree family history of schizophrenia, schizoaffective disorder, or other primary psychotic disorder is a standard exclusion criterion across virtually every published psychedelic-assisted therapy RCT (Goodwin 2022 COMP001; Mitchell 2021/2023 MAPP1/MAPP2; Carhart-Harris 2021; Bogenschutz 2022).
The mechanistic rationale is concrete: classical psychedelics (psilocybin, LSD) act as 5-HT2A receptor agonists, the same receptor system implicated in psychotomimetic effects; MDMA combines serotonergic and dopaminergic release; ketamine is an NMDA antagonist that produces dissociative and frankly psychotomimetic effects even in healthy controls. In a person with a psychotic-disorder diagnosis or genetic vulnerability, these mechanisms can precipitate, prolong, or worsen psychotic symptoms. See the schizophrenia and psychotic disorders article.
Other situations requiring specialised evaluation
- Active mania or hypomania — see the bipolar considerations article.
- Pregnancy, postpartum, breastfeeding — typically excluded from RCTs.
- Active medical instability (acute cardiovascular disease, uncontrolled hypertension, severe hepatic or renal disease, low BMI in eating disorders) — requires stabilisation first.
- Active substance intoxication or recent recreational psychedelic use — increases dosing-day risk.
- Adolescents and minors — the published RCT evidence base is in adults; pediatric PAT is not standard-of-care in Canada.
- Older adults (65+) — Spravato is not Health Canada-recommended in patients aged 65 and over per CDA-AMC review; off-label ketamine in older adults requires comprehensive geriatric assessment.
Sleep disorders and insomnia (honest framing)
Sleep disorders affect roughly one in three Canadian adults in any given year, with chronic insomnia disorder in 10–15% of the population. Cognitive Behavioral Therapy for Insomnia (CBT-I) is foundational first-line treatment per AASM and Canadian Sleep Society guidance.
Psychedelic-assisted therapy is not a sleep medicine. Ketamine, psilocybin, and MDMA acutely disrupt sleep architecture. The relevant clinical situation is comorbidity: insomnia in the context of TRD (where ketamine or Spravato may improve sleep through depression resolution) and nightmares/insomnia in the context of PTSD (where MDMA-AT in the Mitchell 2021/2023 trials reduced nightmare frequency as a secondary outcome via PTSD resolution). Primary insomnia disorder is not an appropriate primary indication. See the sleep disorders and insomnia article.
How decisions get made across conditions
Choosing between Spravato, off-label ketamine, SAP psilocybin, and SAP MDMA is a sequential set of judgements:
- Primary diagnosis and approved options. TRD in adults 18–64 is the only Health Canada-labelled indication (Spravato). Everything else is off-label or SAP.
- Standard-of-care pipeline completed? Non-negotiable for SAP — the regulation requires "conventional treatments have failed, are unsuitable, or are unavailable." For TRD, two adequate antidepressant trials; for PTSD, trauma-focused psychotherapy and SSRI trials; for OCD, ERP and SSRIs; for AUD, evidence-based pharmacotherapy plus psychotherapy.
- Safety profile. Bipolar excludes most psilocybin/MDMA RCT populations; family history of psychotic disorder is the clearest near-absolute exclusion; cardiovascular comorbidity matters for ketamine and MDMA; pregnancy and postpartum status matter universally; active ED medical instability matters.
- Comorbidity pattern. TRD+AUD, PTSD+chronic pain, treatment-resistant OCD with completed ERP — each has different sequencing implications.
- Treatment-experience profile. Past dissociation tolerance, anaesthesia tolerance, benzodiazepine or substance-use history, and prior response to rapid-acting interventions all factor in.
- Accessible pathway. Spravato has private prior-authorisation (PSHCP, Canada Life, Manulife, Sun Life, Green Shield, Alberta Blue Cross PAT); VAC covers ketamine and Spravato for service-related conditions; WSIB/WCB covers ketamine for compensable claims; provincial public formularies generally do not cover Spravato per CDA-AMC; psilocybin/MDMA SAP typically require self-funding, with Quebec RAMQ Farzin/Stephan as the precedent exception.
- Geographic and clinic-access reality. Spravato sites cluster in urban centres; off-label ketamine clinics vary in protocol fidelity; SAP psilocybin and MDMA practitioners are a smaller, more specialised network.
Canadian access pathways across conditions
Practical access hinges on three pathway categories, each with different rules across substances and conditions:
- Health Canada-approved Spravato. The structured pathway. Prescribing happens in clinic-based Spravato programs registered under the JANSSEN JOURNEY™ controlled-distribution program. Private prior-authorisation is the practical insurance pathway; public formularies are restricted per CDA-AMC. See the insurance coverage for psychedelic-assisted therapy guide.
- Off-label ketamine. Legal under standard Canadian off-label prescribing principles. Modalities include intravenous, intramuscular, sublingual, and oral. Costs are typically self-pay for psychiatric off-label use ($400–$1,500 per session depending on modality), with WSIB and VAC coverage for compensable indications. See the ketamine therapy guide and the ketamine insurance coverage guide.
- Health Canada Special Access Program (psilocybin, MDMA). The investigational pathway. The January 5, 2022 SAP amendment made case-by-case requests possible for serious or life-threatening conditions where conventional treatments have failed, are unsuitable, or are unavailable. Practitioners (not therapists alone) submit. Quebec RAMQ has a public-funding precedent (Farzin/Stephan December 2022); other provinces generally require self-pay. See the SAP application process complete guide.
For population-specific pathway considerations — older adults, couples, Indigenous and culturally responsive care, LGBTQ+ patients, family members, adolescents and young adults, healthcare workers, pregnancy/postpartum, and disability/accessibility — see the populations served by psychedelic-assisted therapy. For coordinated-care and integration questions, see the coordinated care and integration guide.
What psychedelic-assisted therapy is NOT
This page has been deliberate about evidence, regulation, and contraindication. The same discipline applies to what is not on offer:
- It is not a cure. Trial response and remission rates are partial; long-term durability varies; some patients do not respond.
- It is not a substitute for standard-of-care treatment. It is an adjunct to or, in carefully selected situations, an alternative to evidence-based first-line treatment that has been adequately tried.
- It is not appropriate for everyone. Comprehensive screening is a non-negotiable input, not a hurdle. Many candidates are screened out for safety reasons, and that screening protects them.
- It is not unsupervised psychedelic use. Recreational, retreat-tourism, and unsupervised dosing carry safety and legal risks that the Canadian SAP / off-label ketamine / Spravato pathways exist specifically to avoid.
- It is not a replacement for opioid agonist therapy in opioid use disorder. OAT is life-saving in the Canadian opioid-poisoning context and remains the primary intervention for OUD.
- It is not a primary treatment for primary insomnia, primary panic disorder, primary personality disorder, or primary eating disorder — comprehensive condition-specific care remains foundational.
- It does not promise specific outcomes for specific patients. Trial-level summary statistics describe groups, not individuals, and do not constitute a forecast of any one person's response.
Frequently asked questions
Is psychedelic-assisted therapy approved in Canada? Only one is Health Canada-approved: esketamine nasal spray (Spravato), for TRD in adults 18–64 in combination with an SSRI or SNRI. Ketamine is approved as an anaesthetic; its use for depression, PTSD, anxiety, OCD, and chronic pain is off-label. Psilocybin and MDMA are accessed only through Health Canada's Special Access Program on a case-by-case basis.
Which conditions has it been most studied for? TRD (Spravato approved; off-label ketamine RCT base; psilocybin investigational with Goodwin 2022); PTSD (MDMA-AT investigational with Mitchell 2021/2023); cancer-related anxiety and end-of-life distress (psilocybin with Griffiths/Ross 2016); alcohol use disorder (psilocybin with Bogenschutz 2022); CRPS and neuropathic chronic pain (off-label ketamine with Sigtermans/Schwartzman 2009).
Is psychedelic-assisted therapy a cure? No. Trial response and remission rates are partial, and durability varies. ATMA CENA does not describe psychedelic-assisted therapy as curative or transformative.
Can I get psilocybin or MDMA outside SAP? No legal, supervised pathway exists outside SAP. Both are CDSA-controlled. Recreational and retreat-tourism use carries legal and safety risks the SAP pathway is designed to avoid.
Is Spravato covered by insurance? Is off-label ketamine? Spravato is on prior-authorisation with most major private insurers (PSHCP, Canada Life, Manulife, Sun Life, Green Shield, Alberta Blue Cross PAT); provincial public drug plans generally do not cover it per the CDA-AMC December 2020 recommendation. Off-label ketamine for psychiatric uses is generally self-pay; WSIB Ontario covers ketamine for compensable chronic pain; VAC covers ketamine for service-related conditions. See the insurance coverage guide and the ketamine insurance coverage guide.
I have bipolar disorder. Is it an option? With significant qualification. Mania-induction risk is central. Off-label ketamine has the strongest bipolar-depression evidence (Diazgranados 2010; Zarate 2012) and can be considered with mood-stabilizer coordination. Spravato is approved for TRD with explicit bipolar exclusion. Psilocybin and MDMA RCTs typically exclude bipolar patients. See the bipolar considerations article.
I have a personal or family history of schizophrenia. Is it safe? This is the clearest near-absolute contraindication — a standard exclusion criterion across virtually every published psychedelic-assisted therapy RCT. See the schizophrenia contraindication article.
I'm pregnant or breastfeeding. Can I do PAT? Pregnant, postpartum, and breastfeeding patients are typically excluded from psilocybin and MDMA RCTs. Spravato's monograph carries lactation caution. Off-label ketamine PPD evidence is very limited. Specialised perinatal-psychiatry consultation is essential. See the postpartum depression article and the pregnancy and postpartum populations article.
I have OCD. Should I try ERP and an SSRI first? Yes. ERP plus higher-dose SSRIs remain foundational first-line for OCD. Psychedelic evidence in OCD is investigational with a small base (Moreno 2006; Rodriguez 2013). See the OCD deep-dive article.
I have suicidal thoughts right now. What should I do? If you or someone you know is in crisis, help is available right now. 9-8-8 Suicide Crisis Helpline (Canada) — call or text 9-8-8, 24/7, bilingual. Talk Suicide Canada — 1-833-456-4566. Quebec — 1-866-APPELLE. PAT is not a substitute for acute crisis care; ketamine and Spravato have rapid-acting SI evidence (Wilkinson 2018; Canuso 2018) as adjuncts integrated with — not instead of — comprehensive crisis care. See the suicidality article.
I have multiple conditions at once. Where do I start? Concurrent disorders are the rule, not the exception. Standard practice is integrated care; sequencing depends on which condition is most disabling, the strongest evidence-base for the specific presentation, and the safety profile. See the concurrent disorders article.
How do I figure out which substance is right for me, and how do I vet a Canadian clinic?
Ketamine versus psilocybin for TRD — what's the difference? Regulatory status (esketamine approved for TRD; ketamine off-label; psilocybin SAP investigational); evidence (multi-RCT for ketamine/Spravato; phase 2 for psilocybin with phase 3 ongoing); mechanism (NMDA antagonism vs 5-HT2A agonism); session structure (twice-weekly induction vs one to two longer dosing days); pathway (private prior-auth, self-pay, SAP self-pay). See the ketamine vs psilocybin comparison.
Sources
- Goodwin GM, Aaronson ST, Alvarez O, et al. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med 2022;387:1637–1648. PMID 36322843.
- Carhart-Harris R, Giribaldi B, Watts R, et al. Trial of Psilocybin versus Escitalopram for Depression. N Engl J Med 2021;384:1402–1411. PMID 33852780.
- Anand A, Mathew SJ, Sanacora G, et al. Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression (ELEKT-D). N Engl J Med 2023;388:2315–2325. PMID 37224232.
- Wajs E, Aluisio L, Holder R, et al. Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: SUSTAIN-2 Phase 3 Open-Label Long-Term Safety. J Clin Psychiatry 2020;81:19m12891. PMID 32316080.
- Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study (MAPP1). Nat Med 2021;27:1025–1033. PMID 33972795.
- Mitchell JM, Ot'alora G M, van der Kolk B, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial (MAPP2). Nat Med 2023;29:2473–2480. PMID 37709999.
- Mithoefer MC, Mithoefer AT, Feduccia AA, et al. MDMA-assisted psychotherapy for posttraumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 trial. Lancet Psychiatry 2018;5:486–497. PMID 29728331.
- Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial. J Psychopharmacol 2016;30:1181–1197. PMID 27909164.
- Ross S, Bossis A, Guss J, et al. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol 2016;30:1165–1180. PMID 27909165.
- Bogenschutz MP, Ross S, Bhatt S, et al. Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry 2022;79:953–962. PMID 36001306.
- Wilkinson ST, Ballard ED, Bloch MH, et al. The effect of a single dose of intravenous ketamine on suicidal ideation: a systematic review and individual participant data meta-analysis. Am J Psychiatry 2018;175:150–158. PMID 28969441.
- Canuso CM, Singh JB, Fedgchin M, et al. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Am J Psychiatry 2018;175:620–630. PMID 29726346.
- Sigtermans MJ, van Hilten JJ, Bauer MC, et al. Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1. Pain 2009;145:304–311. PMID 19604642.
- Schwartzman RJ, Alexander GM, Grothusen JR, et al. Outpatient intravenous ketamine for the treatment of complex regional pain syndrome: a double-blind placebo controlled study. Pain 2009;147:107–115. PMID 19783371.
- Diazgranados N, Ibrahim L, Brutsche NE, et al. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry 2010;67:793–802. PMID 20679587.
- Zarate CA Jr, Brutsche NE, Ibrahim L, et al. Replication of ketamine's antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry 2012;71:939–946. PMID 22297150.
- Peck SK, Shao S, Gruen T, et al. Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. Nat Med 2023;29:1947–1953. PMID 37488291.
- Sewell RA, Halpern JH, Pope HG Jr. Response of cluster headache to psilocybin and LSD. Neurology 2006;66:1920–1922. PMID 16801660.
- Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry 2006;67:1735–1740. PMID 17196053.
- Rodriguez CI, Kegeles LS, Levinson A, et al. Randomized controlled crossover trial of ketamine in obsessive-compulsive disorder: proof-of-concept. Neuropsychopharmacology 2013;38:2475–2483. PMID 23783065.
- Health Canada. Notice to stakeholders: Requests to the Special Access Program (SAP) involving psychedelic-assisted psychotherapy. Effective January 5, 2022. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/requests-special-access-program-psychedelic-assisted-psychotherapy.html
- Health Canada. SPRAVATO (esketamine) nasal spray — Product Monograph (current). DIN 02499290. Janssen Inc. https://pdf.hres.ca/dpd_pm/00076912.PDF
- CDA-AMC (formerly CADTH). Canadian Drug Expert Committee Recommendation: Esketamine (Spravato — Janssen Inc.). December 18, 2020. https://www.cda-amc.ca/sites/default/files/cdr/complete/SR0621%20Spravato%20-%20CDEC%20Final%20Recommendation%20December%2018,%202020_for%20posting.pdf
- Government of Canada. Controlled Drugs and Substances Act, Schedules I and III. https://laws-lois.justice.gc.ca/eng/acts/c-38.8/
- Workplace Safety and Insurance Board (Ontario). Drug formulary listing decision: Ketamine and esketamine. https://www.wsib.ca/en/drug-formulary-listing-decision-ketamine-and-esketamine
- TheraPsil Canada. SAP psilocybin pathway resources. https://therapsil.ca/sap-psilocybin/
- Statistics Canada. Canadian Community Health Survey — Mental Health Component (CCHS-MH). https://www150.statcan.gc.ca/n1/en/catalogue/82M0021X
- 9-8-8 Suicide Crisis Helpline (Canada). https://988.ca/
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