Psilocybin-assisted Interpersonal Therapy for Depression

NCT05581797 | Completed

• 1 other identifier: UOtagoPsilocybin
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label interventional study of psilocybin-assisted interpersonal therapy for treatment resistant depression. 20 participants will be recruited to take part in this 8-week intervention that involves 8 sessions of psychotherapy and 2 doses of psilocybin.

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (2)

• The feasibility of delivery of Psilocybin integrated into Interpersonal Therapy for people with TRD

  Retention rate (participants who complete the full number of treatment sessions).

  Week 10

• The feasibility of recruiting patients with major depression for this treatment in New Zealand

  1. The percentage of potential participants who meet the major inclusion/exclusion criteria during phone screening. 2. The percentage of potential participants who enter the study after the in-person screening (see page 2 for description of two-step screening process).

  Week 0

Secondary Outcomes (7)

• GRID-Hamilton Depression Rating Scale (GRID-HAMD)

  Completed at baseline, week 1,2,3,4,5,6,7,8,9,18

• Social Adjustment Scale - Modified (SAS-M)

  This will be completed at baseline, prior to first dosing, weeks 9 and 18.

• Therapy Goals Measurement (TGM)

  This will be completed at week 2, 9 and 18.

• Antidepressant Discontinuation Symptom Measurement (ADSM)

  This will be completed at week 1,2, and 3.

• Aotearoa Adapted Watts Connectedness Scale (AA-WCS).

  At the end of psilocybin dosing session in Week 4 and Week 5

Study Arms (1)

Psilocybin-assisted psychotherapy

EXPERIMENTAL

Interpersonal Therapy integrated with psilocybin

Other: Psilocybin-assisted psychotherapy

Interventions

Psilocybin-assisted psychotherapy OTHER

8 sessions of interpersonal therapy and 2 doses of psilocybin

Psilocybin-assisted psychotherapy

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
• Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc \> 450 msec), artificial heart valve, or TIA in the past year
• Epilepsy with history of seizures
• Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
• Currently taking psychoactive prescription medication on a regular (e.g., daily) basis which are unable to be ceased (under supervision) during the study period.
• Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including MAOIs. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
• Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
• Current or history within one year of meeting DSM-5 criteria for a moderate or severe alcohol or other drug use disorder (excluding caffeine)
• Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
• Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
• History of a medically significant suicide attempt
• Has failed to respond to electroconvulsive therapy during the current major depressive episode 13Not fluent in English

Sponsors & Collaborators

• University of Otago: lead

Study Sites (1)

University of Otago

Christchurch, 8001, New Zealand

Location

Related Publications (1)

• Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285.

  PMID: 33146667 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Cameron Lacey, PhD

  University of Otago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 17, 2022
• Study Start: March 15, 2023
• Primary Completion: May 6, 2024
• Study Completion: June 4, 2024
• Last Updated: April 9, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)