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

Primary Purpose

Outpatients / Inpatients With Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Escitalopram
Escitalopram+Aripiprazole
Escitalopram+omega-3 PUFAs
Escitalopram+Aripiprazole+omega-3 PUFAs
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Outpatients / Inpatients With Depression focused on measuring major depressive disorder, anhedonia, inflammatory immune, reward system, optimal treatment, neurotransmitter

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Xicheng District Pingan Hosptial
  • Beijing Huilongguan Hospital
  • Peking University Sixth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Escitalopram

Escitalopram + omega-3 PUFAs

Escitalopram + Aripiprazole

Escitalopram + omega-3 PUFAs + Aripiprazole

Arm Description

Escitalopram monotherapy (10-20 mg/day）

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

Escitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day)

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

Outcomes

Primary Outcome Measures

The improvement of anhedonia after 8-week treatment
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.
The improvement of depressive symptoms after 8-week treatment
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

The improvement of anhedonia at early timepoints during the treatment procedure
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.
The improvement of depressive symptoms at early timepoints during the treatment procedure
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.
The improvement of 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.

Full Information

First Posted
May 15, 2022
Last Updated
September 27, 2022
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT05389046
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Outpatients / Inpatients With Depression
Keywords
major depressive disorder, anhedonia, inflammatory immune, reward system, optimal treatment, neurotransmitter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Escitalopram monotherapy (10-20 mg/day）
Arm Title
Escitalopram + omega-3 PUFAs
Arm Type
Experimental
Arm Description
Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）
Arm Title
Escitalopram + Aripiprazole
Arm Type
Experimental
Arm Description
Escitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day)
Arm Title
Escitalopram + omega-3 PUFAs + Aripiprazole
Arm Type
Experimental
Arm Description
Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）and Aripiprazole （2.5-10 mg/day)
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Escitalopram
Intervention Type
Drug
Intervention Name(s)
Escitalopram+Aripiprazole
Intervention Description
Escitalopram+Aripiprazole
Intervention Type
Drug
Intervention Name(s)
Escitalopram+omega-3 PUFAs
Intervention Description
Escitalopram+omega-3 PUFAs
Intervention Type
Drug
Intervention Name(s)
Escitalopram+Aripiprazole+omega-3 PUFAs
Intervention Description
Escitalopram+Aripiprazole+omega-3 PUFAs
Primary Outcome Measure Information:
Title
The improvement of anhedonia after 8-week treatment
Description
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.
Time Frame
Day 0 to Day 56
Title
The improvement of depressive symptoms after 8-week treatment
Description
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.
Time Frame
Day 0 to Day 56
Secondary Outcome Measure Information:
Title
The improvement of anhedonia at early timepoints during the treatment procedure
Description
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.
Time Frame
Day 0 to Day 14, Day 0 to Day 28
Title
The improvement of depressive symptoms at early timepoints during the treatment procedure
Description
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.
Time Frame
Day 0 to Day 14, Day 0 to Day 28
Title
The improvement of anxiety symptoms
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5); Age: 18-55 (including 18 and 55) HAMD-17≥18 DARS ≤ 28 Do not receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months. Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol. Exclusion Criteria: Patients who are diagnosed with major somatic diseases; Patients who meet DSM-5 diagnostic criteria for other mental disorders: Personality disorder, mental retardation; drug and/or alcohol dependence; Patients with severe suicidal tendencies or suicidal behavior; Pregnant or lactating women; Patients with MRI contraindications; Patients who are regarded as unsuitable by investigators for this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tian-Mei Si, Ph.D
Phone
861062723748
Email
sitianmei@bjmu.edu.cn
Facility Information:
Facility Name
Beijing Xicheng District Pingan Hosptial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bai Han, MD.
Phone
86-10-66250226
Email
hanbai@126.com
Facility Name
Beijing Huilongguan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen, MD.
Phone
86-13811004849
Email
chl0175@163.com
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianmei Si, PhD., MD.
Phone
861062723748
Email
si.tian-mei@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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