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Magic mushroom compound shows promise for depression in new trial

NCT ID NCT06746441

Symptom relief Sponsor: Khyber Medical University Peshawar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed phase 2 trial tested whether psilocybin (the active ingredient in magic mushrooms) alone or combined with cognitive behavioral therapy (CBT) can help people with major depression. Sixty adults aged 18-70 with active depression took part. Researchers measured changes in depression scores, anxiety, and biological markers like brain chemicals and inflammation. The goal is to see if psilocybin can offer a new treatment option for depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin (a psychedelic compound from magic mushrooms)
What this could lead to
If it works, this could point toward a new way to treat depression using psilocybin, possibly with fewer side effects than standard antidepressants.
What could go wrong
This is a small, early-phase trial with only 60 people, so results may not apply to everyone. Psilocybin can cause intense psychological effects and is not yet approved for depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Dec 2024

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • Lady Reading Hospital, Pakistan

    Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

More trials for these conditions

Other studies related to the condition(s) this trial covers.