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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05389046

Enrollment

252

Registered

2022-05-24

Start date

2022-08-15

Completion date

2025-12-31

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatients / Inpatients With Depression

Keywords

major depressive disorder, anhedonia, inflammatory immune, reward system, optimal treatment, neurotransmitter

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.

Interventions

DRUGEscitalopram

Escitalopram

DRUGEscitalopram+Aripiprazole

Escitalopram+Aripiprazole

DRUGEscitalopram+omega-3 PUFAs

Escitalopram+omega-3 PUFAs

DRUGEscitalopram+Aripiprazole+omega-3 PUFAs

Escitalopram+Aripiprazole+omega-3 PUFAs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
cognition outcome	Day 0 to Day 56	The outcome is measured by cognition task.

Countries

China

Contacts

Primary ContactTian-Mei Si, Ph.D

sitianmei@bjmu.edu.cn861062723748

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026