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

Not Applicable

Recruiting

• Conditions: Outpatients / Inpatients With Depression
• Interventions: Drug: Escitalopram+Aripiprazole; Drug: Escitalopram; Drug: Escitalopram+Aripiprazole+omega-3 PUFAs; Drug: Escitalopram+omega-3 PUFAs

• Registration Number: NCT05389046
• Lead Sponsor: Peking University

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.

Study Timeline

• Study First Submitted: 2022-05-15
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2022-08-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
17-item Hamilton depression rating scale (HAMD-17) value	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)	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 Outcome Measures

Name	Time	Method
Anxiety symptoms	Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56	The outcome is measured by Hamilton anxiety rating scale (HAMA) total score change. The change value of HAMA total scores at each timepoints compared to the baseline. The maximum score of HAMA is 56 and the minimum is 0. Higher scores mean a worse outcome.

Trial Locations

Locations (3)

Peking University Sixth Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Huilongguan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Xicheng District Pingan Hosptial; 🇨🇳 Beijing, Beijing, China