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

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389046
Collaborator
(none)
252
3
4
42
84
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The improvement of anhedonia after 8-week treatment [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Xicheng District Pingan Hosptial Beijing Beijing China 100035
2 Beijing Huilongguan Hospital Beijing Beijing China 100096
3 Peking University Sixth Hospital Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Si Tianmei, Professor, Peking University Sixth Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022