Psilocybin and Depression

Severe Depression Clinical Trial

— Psilo101  

Official title:

Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03380442
• Other study ID #: 2016-004195-22
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 12, 2017
• Last updated: December 15, 2017
• Start date: September 2018
• Est. completion date: September 2021

Study information

• Verified date: December 2017
• Source: Helsinki University
• Contact: Mona E Moisala, PhD
• Phone: 504480044
• Email: mona.moisala[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).

2. No health-related contraindications.

Exclusion Criteria:

1. Current or previously diagnosed psychotic disorder.

2. Immediate family member with a diagnosed psychotic disorder.

3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).

4. History of suicide attempts.

5. History of mania.

6. Current 5-HT2A antagonist antidepressant medication.

7. Blood or needle phobia.

8. Positive pregnancy test.

9. Current drug or alcohol dependence.

10. Lack of appropriate use of contraception.

11. Breast-feeding.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Severe Depression

Intervention

Drug:
• Psilocybin
Psilocybin ingested orally
• Ketamine (Ketalar)
Ketamine administered intranasally

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University	Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK, Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)	The primary outcome measures in this study will be the mean change in QIDS scores from pre-administration baseline at day 1 to Follow-up 2 at day 103 (3 months after the administration session). Additionally, an electronic version of the QIDS will be performed 6 months after the administration session. The criteria for determining response will be a reduction of 25% in the (QIDS; Rush et al., 2003) scores from baseline (screening), and remission will be scores of =5 on the QIDS.	6 months
Secondary	The Montgomery and Asberg Depression Rating Scale	The Montgomery and Asberg Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).	3 months
Secondary	Hamilton Depression Rating Scale	The Hamilton Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).	3 months

External Links

•   Web page of Psychiatry Center, where study is carried out