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CompletedPhase 2

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

NCT06746441 · Khyber Medical University Peshawar

Closed to entry
Status
Not accepting participants
Phase 2
Phase
60
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This randomized controlled clinical trial evaluates the effectiveness of psilocybin and psilocybin-assisted cognitive behavioral therapy (CBT) in the management of Major Depressive Disorder (MDD). The study aims to compare the effects of psilocybin-only therapy, CBT, and psilocybin-assisted CBT on depression symptoms, neurochemical markers, inflammatory markers, and neuroplasticity in individuals with MDD. Participants will continue their routine depression medications and will be assessed for changes in depression scores, biochemical markers, and brain activity patterns using validated tools and tests.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Depression Scores (Hamilton Depression Rating)

    Measured over Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).

  • Change in Depression Scores (Montgomery-Åsberg Depression Rating Scale)

    Measured over Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).

  • Change in Depression Scores (Beck Depression Inventory)

    Measured over Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).

  • Change in Anxiety Scores (Beck Anxiety Inventory)

    Measured over Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Lady Reading Hospital, PakistanPeshawarKhyber PakhtunkhwaPakistan

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06746441 on ClinicalTrials.gov →

Last updated in the registry 2025-09-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 2 trials from Khyber Medical University Peshawar →