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

Peking University

Status: Enrolling

Conditions: Outpatients / Inpatients With Depression

Treatments: Drug: Escitalopram; Drug: Escitalopram+Aripiprazole+omega-3 PUFAs; Drug: Escitalopram+Aripiprazole; Drug: Escitalopram+omega-3 PUFAs

Study type: Interventional

Funder types: Other

Identifiers

NCT05389046

2022-1-4111

Details and patient eligibility

About

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

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 4 patient groups

Escitalopram

Experimental group

Description:

Escitalopram monotherapy (10-20 mg/day）

Treatment:

Drug: Escitalopram

Escitalopram + omega-3 PUFAs

Experimental group

Description:

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

Treatment:

Drug: Escitalopram+omega-3 PUFAs

Escitalopram + Aripiprazole

Experimental group

Description:

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

Treatment:

Drug: Escitalopram+Aripiprazole

Escitalopram + omega-3 PUFAs + Aripiprazole

Experimental group

Description:

Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）and Aripiprazole （2.5-10 mg/day)

Treatment:

Drug: Escitalopram+Aripiprazole+omega-3 PUFAs