Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinCompleted

Psilocybin-assisted Interpersonal and Social Rhythm Therapy for Depression

Single-arm, open-label interventional study (n=20 planned, ACTUAL registry count=5) of psilocybin-assisted interpersonal therapy for treatment-resistant major depression; two psilocybin doses plus eight psychotherapy sessions.

Target Enrollment
5 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

Single-arm, open-label feasibility study integrating interpersonal psychotherapy (IPT) with two supervised psilocybin dosing sessions for people with treatment‑resistant major depressive disorder.

The 10‑week intervention comprises three IPT preparation sessions, two dosing/debriefing sessions, five integration sessions, and follow-up at week 18; antidepressant discontinuation and safety monitoring (ECG, labs, urine drug and pregnancy tests) are supervised by consultant psychiatrists.

Study Protocol

Preparation

3 sessions

Dosing

2 sessions

Integration

5 sessions

Therapeutic Protocol

other

Study Arms & Interventions

Psilocybin-assisted psychotherapy

experimental

Interpersonal psychotherapy integrated with two psilocybin dosing sessions (single-arm, open-label).

Interventions

  • Psilocybin
    via Oral• two doses• 2 doses total

    Two psilocybin dosing sessions integrated with IPT (no per-dose mg specified in registry fragment).

  • Compound

    Eight IPT sessions (3 preparation, 2 dosing/debriefing, 5 integration) delivered alongside psilocybin.

Participants

Ages
21 – 75
Sexes
Male & Female

Inclusion Criteria

  • 1. Able to give written informed consent
  • 2. Have a confirmed DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode and no improvement despite two adequate courses of antidepressant treatment of different pharmacological classes lasting at least 6 weeks within the current depressive episode
  • 3. Have a baseline total score of >13 on HAMD17
  • 4. Agree to discontinue any recommended psychoactive medications, including antidepressants and lithium as part of the study
  • 5. Agree to refrain from using alcohol and other substances including nicotine, within 24 hours of each drug administration
  • 6. Be judged by study team clinicians to be at low risk for suicidality
  • 7. Be medically stable as determined by screening (history, exam, ECG, routine labs)
  • 8. Agree to consume approximately the same amount of caffeine-containing beverage on the mornings of drug session days
  • 9. Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration
  • 10. Agree that for one week before each drug session, they will refrain from taking any non-prescription medication, nutritional supplement, or herbal supplement except when approved by the investigators
  • 11. If female, agree to pregnancy testing and regular contraception while in study
  • 12. Have limited lifetime use of hallucinogens (preferred: no use in past 5 years; total use <10 times)
  • 13. Agree to participate in a 10-week combined psychotherapy and psilocybin intervention and complete follow-up at week 18

Exclusion Criteria

  • 1. Pregnant or nursing women, or women of child-bearing potential not using effective contraception
  • 2. Cardiovascular conditions (coronary artery disease, stroke, angina, uncontrolled hypertension, clinically significant ECG abnormality, prolonged QTc >450 msec, artificial heart valve, TIA in past year)
  • 3. Epilepsy with history of seizures
  • 4. Insulin-dependent diabetes or history of hypoglycaemia if on oral hypoglycaemics
  • 5. Currently taking psychoactive prescription medication on a regular basis which cannot be ceased during the study
  • 6. Regular use of centrally acting serotonergic medications, including MAOIs (psilocybin sessions postponed until 5 half-lives elapsed for intermittent use)
  • 7. Current or past history of schizophrenia spectrum or other psychotic disorders, or Bipolar I/II Disorder
  • 8. Moderate or severe alcohol or other drug use disorder within past year (excluding caffeine)
  • 9. First- or second-degree relative with schizophrenia spectrum or other psychotic disorders, or Bipolar I/II Disorder
  • 10. Psychiatric condition judged incompatible with safe exposure to psilocybin
  • 11. History of a medically significant suicide attempt
  • 12. Failure to respond to ECT during the current major depressive episode
  • 13. Not fluent in English

Study Details

Locations

University of Otago — Christchurch, New Zealand

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