Using psilocybin and therapy to treat major depression
Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers: a Randomized Controlled Trial
This study is testing whether psilocybin alone or with therapy can help people with major depression feel better compared to standard therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 1 site (Peshawar, Khyber Pakhtunkhwa) |
| Trial ID | NCT06746441 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of psilocybin alone and in combination with cognitive behavioral therapy (CBT) for managing Major Depressive Disorder (MDD). It involves 60 participants who will be randomized into four groups: a control group receiving conventional therapy, a psilocybin therapy group, a CBT group, and a psilocybin-assisted CBT group. Over 10 weeks, participants will receive interventions, including two doses of psilocybin and structured CBT sessions, while their depression symptoms and various biochemical markers will be monitored. The study aims to assess improvements in depression scores and changes in neurochemical and inflammatory markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with Major Depressive Disorder and currently on a stable SSRI medication.
Not a fit: Patients with concurrent psychiatric disorders or those at risk of suicidal tendencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with Major Depressive Disorder, particularly those who are treatment-resistant.
How similar studies have performed: Other studies have shown promising results with psilocybin in treating depression, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 18-70 years. * Diagnosed with Major Depressive Disorder (MDD) according to DSM-V criteria. * Active depressive symptoms as indicated by a score \> 16 on the Hamilton Depression * Rating Scale (HAM-D) over the preceding two weeks. * Female participants of childbearing potential must be using a highly effective form of contraception and willing to maintain contraceptive use throughout the study period. * Participants must have been taking one SSRI antidepressant (e.g., citalopram, escitalopram, fluoxetine) for at least 6 weeks with at least 75% adherence. Exclusion Criteria: * Resting blood pressure \>140/90 (average of four separate measurements). * Risk of suicidal tendencies as indicated by a score of 3 or higher on item 3 of the HAM-D scale. * Use of multiple SSRIs or any antidepressant not specified in the inclusion criteria. * Presence of concurrent psychiatric disorders (e.g., bipolar disorder, schizophrenia). * Use of psychedelics or ketamine within the last 12 months. * Pregnancy, breastfeeding, or attempting to conceive. * History of substance abuse or alcohol use in the last 6 months. * Cardiovascular conditions (e.g., hypertension, stroke history). * History of seizures or epilepsy. * Diabetes (especially insulin-dependent).
Where this trial is running
Peshawar, Khyber Pakhtunkhwa
- Lady Reading Hospital, Pakistan — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr Mahvash Khan — Hayat Abad Medical Complex, Peshawar.
- Study coordinator: Dr Omar Malik, PHD
- Email: omermalik@kmu.edu.pk
- Phone: +92 333 5196243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.