Clinical trial NCT05389046: Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
Official title: Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Outpatients / Inpatients With Depression
Keywords: major depressive disorder
anhedonia
inflammatory immune
reward system
optimal treatment
neurotransmitter
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 17-item Hamilton depression rating scale (HAMD-17) value
timeFrame: Day 0 to Day 56
measure: Anhedonia level-Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Day 0 to Day 56
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Other outcomes:
measure: cognition outcome
timeFrame: Day 0 to Day 56
Locations:
city: Beijing
country: China
facility: Beijing Xicheng District Pingan Hosptial
state: Beijing
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
Study officials:
References: