BridgeMD
New treatment option for Major Depressive Disorder
Official title Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder
ClinicalTrials.gov ID: NCT07703722
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Trauma-related Major Depressive Disorder (MDD) is frequently associated with poor response to conventional antidepressants, persistent psychological distress, and alterations in gut-brain axis function. Existing assessment tools primarily diagnose depression or PTSD but provide limited guidance for integrated clinical management.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Adults aged 18-60 years.
- Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria.
- Trauma-related depression with clinically significant trauma symptoms.
- Hamilton Depression Rating Scale (HAM-D) score \>16.
- PTSD Checklist for DSM-5 (PCL-5) score \>33.
You likely can't join if
- Significant cardiovascular disease.
- Clinically significant hepatic or renal impairment.
- Significant neurological disorders.
- Current or past psychotic disorder or bipolar disorder.
- Current substance or alcohol use disorder, including ketamine or psychedelic drug use.
- Use of more than one antidepressant medication.
See the full eligibility criteria
- Adults aged 18-60 years.
- Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria.
- Trauma-related depression with clinically significant trauma symptoms.
- Hamilton Depression Rating Scale (HAM-D) score \>16.
- PTSD Checklist for DSM-5 (PCL-5) score \>33.
- Generalized Anxiety Disorder-7 (GAD-7) score \>10.
- Receiving a stable single SSRI antidepressant regimen for at least 6 weeks before enrollment with adequate treatment adherence.
- Able and willing to provide written informed consent.
- Willing to comply with all study procedures and follow-up visits.
- Women of childbearing potential must agree to use effective contraception throughout the study.
- Significant cardiovascular disease.
- Clinically significant hepatic or renal impairment.
- Significant neurological disorders.
- Current or past psychotic disorder or bipolar disorder.
- Current substance or alcohol use disorder, including ketamine or psychedelic drug use.
- Use of more than one antidepressant medication.
- Pregnancy, planned pregnancy, or breastfeeding.
- Known hypersensitivity or contraindication to psilocybin.
- Participation in another treatment clinical trial within the previous 30 days.
- Inability or unwillingness to provide informed consent.
- Any medical or psychiatric condition that, in the investigator's opinion, would interfere with safe participation or study assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Islamabad, Capital, Pakistan
- Peshawar, KPK, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Islamabad, Capital, Pakistan; Peshawar, KPK, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.