Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05581797




Registration number
NCT05581797
Ethics application status
Date submitted
2/10/2022
Date registered
17/10/2022
Date last updated
13/03/2023

Titles & IDs
Public title
Psilocybin-assisted Interpersonal Therapy for Depression
Scientific title
Psilocybin-assisted Interpersonal Therapy for Depression
Secondary ID [1] 0 0
UOtagoPsilocybin
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Treatment-Resistant 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Psilocybin-assisted psychotherapy

Experimental: Psilocybin-assisted psychotherapy - Interpersonal Therapy integrated with psilocybin


Other interventions: Psilocybin-assisted psychotherapy
8 sessions of interpersonal therapy and 2 doses of psilocybin
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The feasibility of delivery of Psilocybin integrated into Interpersonal Therapy for people with TRD
Timepoint [1] 0 0
Week 10
Primary outcome [2] 0 0
The feasibility of recruiting patients with major depression for this treatment in New Zealand
Timepoint [2] 0 0
Week 0
Secondary outcome [1] 0 0
GRID-Hamilton Depression Rating Scale (GRID-HAMD)
Timepoint [1] 0 0
Completed at baseline, week 1,2,3,4,5,6,7,8,9,18
Secondary outcome [2] 0 0
Social Adjustment Scale - Modified (SAS-M)
Timepoint [2] 0 0
This will be completed at baseline, prior to first dosing, weeks 9 and 18.
Secondary outcome [3] 0 0
Therapy Goals Measurement (TGM)
Timepoint [3] 0 0
This will be completed at week 2, 9 and 18.
Secondary outcome [4] 0 0
Antidepressant Discontinuation Symptom Measurement (ADSM)
Timepoint [4] 0 0
This will be completed at week 1,2, and 3.
Secondary outcome [5] 0 0
Aotearoa Adapted Watts Connectedness Scale (AA-WCS).
Timepoint [5] 0 0
At the end of psilocybin dosing session in Week 4 and Week 5
Secondary outcome [6] 0 0
Revised Mystical Experiences Questionnaire (MEQ30)
Timepoint [6] 0 0
At the end of psilocybin dosing session in Week 4 and Week 5
Secondary outcome [7] 0 0
Qualitative interview
Timepoint [7] 0 0
Week 18

Eligibility
Key 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 for medical problems via a personal
interview, a medical questionnaire, a physical examination, an electrocardiogram
(ECG), and routine medical blood and urinalysis laboratory tests

8. Agree to consume approximately the same amount of caffeine-containing beverage (e.g.,
coffee, tea) that he/she consumes on a usual morning, before arriving at the research
unit 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, he/she will refrain from taking any
non-prescription medication, nutritional supplement, or herbal supplement except when
approved by the study investigators. Exceptions will be evaluated by the study
investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs,
and common doses of vitamins and minerals.

11. If female, they must agree to pregnancy testing and regular contraception while in
study.

12. Have limited lifetime use of hallucinogens (the following criteria are preferred: no
use in the past 5 years; total hallucinogen use less than 10 times)

13. Agree to participate in a 10-week combined psychotherapy and psilocybin intervention,
complete required measurements (including follow-up measures at week 18) and adhere to
safety protocols.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.

2. 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

3. Epilepsy with history of seizures

4. Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of
hypoglycemia

5. Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
which are unable to be ceased (under supervision) during the study period.

6. 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.

7. 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

8. Current or history within one year of meeting DSM-5 criteria for a moderate or severe
alcohol or other drug use disorder (excluding caffeine)

9. 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

10. Has a psychiatric condition judged to be incompatible with establishment of rapport or
safe exposure to psilocybin

11. History of a medically significant suicide attempt

12. Has failed to respond to electroconvulsive therapy during the current major depressive
episode 13Not fluent in English

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05581797
Trial related presentations / publications
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. Erratum In: JAMA Psychiatry. 2021 Feb 10;:
Public notes

Contacts
Principal investigator
Name 0 0
Cameron Lacey, PhD
Address 0 0
University of Otago
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05581797