Brain and genetic tests to predict relapse in depression
Neurobiological and Genomic Predictors of Relapse After Discontinuation of Antidepressant Treatment in Major Depressive Disorder: An Observational Prospective Study
This project will test whether people with major depressive disorder can safely stop antidepressants once their brain and genetic measures look normal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Uskudar University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07328373 on ClinicalTrials.gov |
What this trial studies
This is a prospective, healthy-controlled observational case-control study that follows outpatients with major depressive disorder over time while they receive antidepressant treatment. Participants undergo repeated quantitative EEG, event-related potentials (including P300), overnight sleep EEG, standardized Hamilton Depression Rating Scale interviews, and blood draws for genetic analysis at least three times during the treatment period. Results from patients will be compared to healthy control participants to identify neurobiological and genomic patterns linked to relapse after medication discontinuation. The aim is to find objective markers that could guide clinicians about when stopping medication carries lower risk of recurrence.
Who should consider this trial
Good fit: Ideal candidates are outpatients who meet DSM-5-TR criteria for major depressive disorder, are willing to undergo repeated EEGs and blood draws, and meet the protocol requirement of being drug-free for at least one week when specified.
Not a fit: People with neurological or other psychiatric comorbidities, hearing loss, significant physical illnesses, or those judged at high risk of relapse are unlikely to benefit from the study's discontinuation guidance.
Why it matters
Potential benefit: If successful, this could help clinicians stop antidepressants sooner for some people while lowering the chances of unexpected relapse.
How similar studies have performed: Previous work has suggested EEG and genetic markers may relate to relapse risk, but findings are mixed and no definitive clinical markers are yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Outpatients * For patients, satisfying Major Depressive Disorder for Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) * Drug-free for at least 1-week Exclusion Criteria: * Any neurological and psychiatric comorbid conditions * Hearing loss * Physical diseases
Where this trial is running
Istanbul
- Prof. Dr. Kemal Arıkan's Psychiatry Clinic — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Mehmet Kemal Arıkan, Prof. — Kemal Arikan Psychiatry Clinic
- Study coordinator: Mehmet Kemal Arıkan, Prof.
- Email: mkarikan46@gmail.com
- Phone: +905325555005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.