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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
252
Beijing Xicheng District Pingan Hosptial
Beijing, Beijing Municipality, China
RECRUITINGBeijing Huilongguan Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Sixth Hospital
Beijing, Beijing Municipality, China
RECRUITING17-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.
Time frame: 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.
Time frame: Day 0 to Day 56
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.
Time frame: Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
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Escitalopram+Aripiprazole+omega-3 PUFAs