Effect of Psilocybin Only and Psilocybin Assisted... — Clinical Trial Details

Phase II interventional

Randomized, single Blind

This randomized, single-masked, parallel-group trial will randomize 60 adults with DSM‑V major depressive disorder to one of four arms: routine care, psilocybin only, CBT only, or psilocybin-assisted CBT. Psilocybin is given in two oral sessions six weeks apart; CBT comprises 8–10 structured 90‑minute sessions.

Outcomes include change in depressive symptoms (HAM‑D, MADRS, BDI), immune and inflammatory markers (CD4/CD8, TNF‑α, IL‑6, resistin, visfatin), neuroplasticity markers (BDNF, oxytocin) and EEG measures; analyses will use ANOVA with Tukey post‑hoc tests.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Lady Reading Hospital, Pakistan — Peshawar, Khyber Pakhtunkhwa, Pakistan

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 use a highly effective form of contraception and maintain use throughout the study.
Participants must have been taking one SSRI antidepressant (e.g., citalopram, escitalopram, fluoxetine) for at least 6 weeks with ≥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).

Start: 2024-12-01

End: 2025-07-01

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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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin Therapy

Interventions

Control

Interventions

CBT

Interventions

Psilocybin + CBT

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators