NCT06746441CompletedPhase 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
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 9 Dec 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Khyber Medical University Peshawar
- Diseases
- Depression
- NCT number
- NCT06746441
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 1 Dec 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of concurrent psychiatric disorders (e.g., bipolar disorder, schizophrenia).
Other illness
- 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).
Other
- 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.
- Use of psychedelics or ketamine within the last 12 months.
- Pregnancy, breastfeeding, or attempting to conceive.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lady Reading Hospital, Pakistan Coordinator of this site? Confirm its status | Peshawar | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.