Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
Overview
- Phase
- Not Applicable
- Intervention
- Escitalopram
- Conditions
- Outpatients / Inpatients With Depression
- Sponsor
- Peking University
- Enrollment
- 252
- Locations
- 3
- Primary Endpoint
- 17-item Hamilton depression rating scale (HAMD-17) value
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a multicenter clinical research and focuses on the exploring of optimal diagnosis and treatment strategies of MDD based on anhedonia.
Detailed Description
Major depressive disorder (MDD) is a heterogeneious psychiatric disorder with complex etiology and pathogenesis. The lack of objective criteria for diagnosis and the use of trial-and-error treatment strategy are the current challenge. Anhedonia is the core symptom of MDD and the aberrant reward system and abnormal inflammatory immune may be the pathological mechanisms. Previous evidence suggests anhedonia cannot be improved quickly and efficiently by taking the first-line antidepressants. This study focuses on exploring the optimal diagnosis and treatment strategy for MDD patients with anhedonia. Based on the hypothesis of inflammatory-immune system，neurotransmitter abnormalities and aberrant reward system, this study aims to evaluate the efficacy and safety of the combinations of escitalopram and aripiprazole and/or omega-3 polyunsaturated fatty acids for MDD patients with anhedonia with a factorial design. Moreover, the multidimensional data including the clinicopathological features, neuroimaging data (MRI) and inflammatory cytokines will be used to establish the model of diagnosis and treatment strategy.
Investigators
Si Tianmei
Professor
Peking University Sixth Hospital
Eligibility Criteria
Inclusion Criteria
- •Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
- •Age: 18-55 (including 18 and 55)
- •Do not receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months.
- •Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol.
Exclusion Criteria
- •Patients who are diagnosed with major somatic diseases;
- •Patients who meet DSM-5 diagnostic criteria for other mental disorders: Personality disorder, mental retardation; drug and/or alcohol dependence;
- •Patients with severe suicidal tendencies or suicidal behavior;
- •Pregnant or lactating women;
- •Patients with MRI contraindications;
- •Patients who are regarded as unsuitable by investigators for this clinical trial.
Arms & Interventions
Escitalopram
Escitalopram monotherapy (10-20 mg/day）
Intervention: Escitalopram
Escitalopram + omega-3 PUFAs
Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）
Intervention: Escitalopram+omega-3 PUFAs
Escitalopram + Aripiprazole
Escitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day)
Intervention: Escitalopram+Aripiprazole
Escitalopram + omega-3 PUFAs + Aripiprazole
Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）and Aripiprazole （2.5-10 mg/day)
Intervention: Escitalopram+Aripiprazole+omega-3 PUFAs
Outcomes
Primary Outcomes
17-item Hamilton depression rating scale (HAMD-17) value
Time Frame: Day 0 to Day 56
The value of 17-item Hamilton depression rating scale (HAMD-17) total score treatment compared to that at the baseline. The maximum score of HAMD-17 is 51 and the minimum is 0. Higher scores mean a worse outcome.
Anhedonia level-Dimensional Anhedonia Rating Scale (DARS)
Time Frame: Day 0 to Day 56
The outcome is measured by Dimensional Anhedonia Rating Scale (DARS) total score. The maximum score of DARS total score is 68 and the minimum is 0. Higher scores mean a better outcome.
Secondary Outcomes
- Anxiety symptoms(Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56)