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

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ClinicalTrials.gov Identifier: NCT05389046
Recruitment Status : Not yet recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University Sixth Hospital

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.

Condition or disease Intervention/treatment Phase
Outpatients / Inpatients With Depression Drug: Escitalopram Drug: Escitalopram+Aripiprazole Drug: Escitalopram+omega-3 PUFAs Drug: Escitalopram+Aripiprazole+omega-3 PUFAs Not Applicable

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 and inflammatory cytokines will be used to establish the model of diagnosis and treatment strategy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escitalopram
Escitalopram monotherapy (10-20 mg/day)
Drug: Escitalopram
Escitalopram

Experimental: Escitalopram + omega-3 PUFAs
Escitalopram (10-20 mg/day)combined with omega-3 PUFAs (EPA 900mg,DHA 300 mg)
Drug: Escitalopram+omega-3 PUFAs
Escitalopram+omega-3 PUFAs

Experimental: Escitalopram + Aripiprazole
Escitalopram (10-20 mg/day)combined with Aripiprazole (2.5-10 mg/day)
Drug: Escitalopram+Aripiprazole
Escitalopram+Aripiprazole

Experimental: Escitalopram + omega-3 PUFAs + Aripiprazole
Escitalopram (10-20 mg/day)combined with omega-3 PUFAs (EPA 900mg,DHA 300 mg)and Aripiprazole (2.5-10 mg/day)
Drug: Escitalopram+Aripiprazole+omega-3 PUFAs
Escitalopram+Aripiprazole+omega-3 PUFAs




Primary Outcome Measures :
  1. The improvement of anhedonia after 8-week treatment [ Time Frame: Day 0 to Day 56 ]
    The change value of Dimensional Anhedonia Rating Scale (DARS) total score after 8-weeks treatment compared to that at the baseline. The maximum score of DARS total score is 68 and the minimum is 0. Higher scores mean a better outcome.

  2. The improvement of depressive symptoms after 8-week treatment [ Time Frame: Day 0 to Day 56 ]
    The change value of 17-item Hamilton depression rating scale (HAMD-17) total score after 8-weeks 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.


Secondary Outcome Measures :
  1. The improvement of anhedonia at early timepoints during the treatment procedure [ Time Frame: Day 0 to Day 14, Day 0 to Day 28 ]
    The outcome is measured by Dimensional Anhedonia Rating Scale (DARS) total score. The change value of DARS total scores at early time points compared to that at the baseline. The maximum score of DARS total score is 68 and the minimum is 0. Higher scores mean a better outcome.

  2. The improvement of depressive symptoms at early timepoints during the treatment procedure [ Time Frame: Day 0 to Day 14, Day 0 to Day 28 ]
    This outcome is measured by 17-item Hamilton depression rating scale (HAMD-17) total score. The change value of HAMD-17 total scores at early time points 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.

  3. The improvement of anxiety symptoms [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 according to International Neuropsychiatric Interview Version 7.0-Suicide Module (MINI7.0-Suicide Module).
  4. Pregnant or lactating women;
  5. Patients with MRI contraindications;
  6. Patients who are regarded as unsuitable by investigators for this clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389046


Contacts
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Contact: Tian-Mei Si, Ph.D 861062723748 sitianmei@bjmu.edu.cn

Locations
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China, Beijing
Beijing Xicheng District Pingan Hosptial
Beijing, Beijing, China, 100035
Contact: Bai Han, MD.    86-10-66250226    hanbai@126.com   
Beijing Huilongguan Hospital
Beijing, Beijing, China, 100096
Contact: Lin Chen, MD.    86-13811004849    chl0175@163.com   
Peking University Sixth Hospital
Beijing, Beijing, China, 100191
Contact: Tianmei Si, PhD., MD.    861062723748    si.tian-mei@163.com   
Sponsors and Collaborators
Peking University
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Responsible Party: Si Tianmei, Professor, Peking University Sixth Hospital
ClinicalTrials.gov Identifier: NCT05389046    
Other Study ID Numbers: 2022-1-4111
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Si Tianmei, Peking University Sixth Hospital:
major depressive disorder
anhedonia
inflammatory immune
reward system
optimal treatment
neurotransmitter
Additional relevant MeSH terms:
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Anhedonia
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Dexetimide
Aripiprazole
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists