Exploring the best diagnosis and treatment for major depressive disorder focusing on anhedonia
Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
This study is testing different treatment options for people with major depressive disorder who struggle with a lack of pleasure in life to see which ones work best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 3 sites (Beijing, Beijing and 2 other locations) |
| Trial ID | NCT05389046 on ClinicalTrials.gov |
What this trial studies
This multicenter clinical research investigates optimal diagnosis and treatment strategies for patients with major depressive disorder (MDD) who experience anhedonia. The study addresses the challenges of MDD, including the lack of objective diagnostic criteria and the inefficacy of first-line antidepressants for anhedonia. It evaluates the safety and efficacy of various treatment combinations, including escitalopram with aripiprazole and/or omega-3 polyunsaturated fatty acids, while utilizing multidimensional data such as neuroimaging and inflammatory cytokines to inform treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 diagnosed with major depressive disorder who exhibit significant anhedonia.
Not a fit: Patients with other mental disorders, severe suicidal tendencies, or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and targeted treatment options for patients suffering from major depressive disorder with anhedonia.
How similar studies have performed: While there is ongoing research in this area, this study's specific approach to combining treatments based on anhedonia and inflammatory mechanisms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5); 2. Age: 18-55 (including 18 and 55) 3. HAMD-17≥18 4. DARS ≤ 28 5. Do not receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months. 6. Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol. Exclusion Criteria: 1. Patients who are diagnosed with major somatic diseases; 2. Patients who meet DSM-5 diagnostic criteria for other mental disorders: Personality disorder, mental retardation; drug and/or alcohol dependence; 3. Patients with severe suicidal tendencies or suicidal behavior; 4. Pregnant or lactating women; 5. Patients with MRI contraindications; 6. Patients who are regarded as unsuitable by investigators for this clinical trial.
Where this trial is running
Beijing, Beijing and 2 other locations
- Beijing Xicheng District Pingan Hosptial — Beijing, Beijing, China (Recruiting)
- Beijing Huilongguan Hospital — Beijing, Beijing, China (Recruiting)
- Peking University Sixth Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Tian-Mei Si, Ph.D
- Email: sitianmei@bjmu.edu.cn
- Phone: 861062723748
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.