Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2025-12-31

Brief Summary

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This study is a multicenter clinical research and focuses on the exploring of optimal diagnosis and treatment strategies of MDD based on anhedonia.

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Detailed Description

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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.

Conditions

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Outpatients / Inpatients With Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Escitalopram

Escitalopram monotherapy (10-20 mg/day）

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Escitalopram

Escitalopram + omega-3 PUFAs

Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）

Group Type EXPERIMENTAL

Escitalopram+omega-3 PUFAs

Intervention Type DRUG

Escitalopram+omega-3 PUFAs

Escitalopram + Aripiprazole

Escitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day)

Group Type EXPERIMENTAL

Escitalopram+Aripiprazole

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

Escitalopram+Aripiprazole+omega-3 PUFAs

Intervention Type DRUG

Escitalopram+Aripiprazole+omega-3 PUFAs

Interventions

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Escitalopram

Intervention Type DRUG

Escitalopram+Aripiprazole

Intervention Type DRUG

Escitalopram+omega-3 PUFAs

Intervention Type DRUG

Escitalopram+Aripiprazole+omega-3 PUFAs

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No