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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | Escitalopram monotherapy (10-20 mg/day） |
|
| Escitalopram + omega-3 PUFAs | Experimental | Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg） |
|
| Escitalopram + Aripiprazole | Experimental | Escitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day) |
|
| Escitalopram + omega-3 PUFAs + Aripiprazole | Experimental | Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）and Aripiprazole （2.5-10 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Escitalopram |
| |
| Escitalopram+Aripiprazole |
| Measure | Description | Time Frame |
|---|---|---|
| 17-item Hamilton depression rating scale (HAMD-17) value | 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. | Day 0 to Day 56 |
| Anhedonia level-Dimensional Anhedonia Rating Scale (DARS) | 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. | Day 0 to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety symptoms | 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. | Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| cognition outcome | The outcome is measured by cognition task. | Day 0 to Day 56 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian-Mei Si, Ph.D | Contact | 861062723748 | sitianmei@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Xicheng District Pingan Hosptial | Recruiting | Beijing | Beijing Municipality | 100035 | China |
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| Drug |
Escitalopram+Aripiprazole |
|
| Escitalopram+omega-3 PUFAs | Drug | Escitalopram+omega-3 PUFAs |
|
| Escitalopram+Aripiprazole+omega-3 PUFAs | Drug | Escitalopram+Aripiprazole+omega-3 PUFAs |
|
| Beijing Huilongguan Hospital | Recruiting | Beijing | Beijing Municipality | 100096 | China |
|
| Peking University Sixth Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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