Outpatients / Inpatients With DepressionNCT05389046
Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
A study testing Escitalopram, Escitalopram+Aripiprazole and Escitalopram+omega-3 PUFAs in people with Outpatients / Inpatients With Depression, run by Peking University at 3 sites in China.
Trial summary
This study is a multicenter clinical research and focuses on the exploring of optimal diagnosis and treatment strategies of MDD based on anhedonia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Outpatients / Inpatients With Depression
- What is being tested?
- Escitalopram, Escitalopram+Aripiprazole and Escitalopram+omega-3 PUFAs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 3 sitesChina
- Study dates
- 15 Aug 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Xicheng District Pingan Hosptial
Beijing, Beijing Municipality, 100035
Bai Han, MD., 86-10-66250226, hanbai@126.com
- Recruiting
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, 100096
Lin Chen, MD., 86-13811004849, chl0175@163.com
- Recruiting
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
Tianmei Si, PhD., MD., 861062723748, si.tian-mei@163.com
About this study
This study is a multicenter clinical research and focuses on the exploring of optimal diagnosis and treatment strategies of MDD based on anhedonia.
Read the 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 (MRI) and inflammatory cytokines will be used to establish the model of diagnosis and treatment strategy.
- Conditions
- Outpatients / Inpatients With Depression
- Being tested
- Escitalopram, Escitalopram+Aripiprazole, Escitalopram+omega-3 PUFAs, Escitalopram+Aripiprazole+omega-3 PUFAs
- Keywords
- major depressive disorder, anhedonia, inflammatory immune, reward system, optimal treatment, neurotransmitter
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Escitalopram
Escitalopram+AripiprazoleDrug
Escitalopram+Aripiprazole
Escitalopram+omega-3 PUFAsDrug
Escitalopram+omega-3 PUFAs
Escitalopram+Aripiprazole+omega-3 PUFAsDrug
Escitalopram+Aripiprazole+omega-3 PUFAs
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Escitalopram monotherapy (10-20 mg/day） Receives: Drug: Escitalopram |
| Escitalopram + omega-3 PUFAs | Experimental | Escitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg） Receives: Drug: Escitalopram+omega-3 PUFAs |
| Escitalopram + Aripiprazole | Experimental | Escitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day) Receives: Drug: Escitalopram+Aripiprazole |
| 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) Receives: Drug: Escitalopram+Aripiprazole+omega-3 PUFAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 to Day 56
Secondary outcomes (1)
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.
Measured: Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start15 Aug 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatients / Inpatients With DepressionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389046
- Sponsor's protocol ID
- 2022-1-4111
- Status last verified
- Jan 2024
- First submitted
- 15 May 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia
- ClinicalTrials.gov ID
- NCT05389046
- Acronym / sponsor ID
- 2022-1-4111
- Conditions
- Outpatients / Inpatients With Depression
- Keywords
- major depressive disorder, anhedonia, inflammatory immune, reward system, optimal treatment, neurotransmitter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (MRI) and inflammatory cytokines will be used to establish the model of diagnosis and treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: EscitalopramEscitalopram monotherapy (10-20 mg/day） |
| Escitalopram + omega-3 PUFAs | Experimental | Drug: Escitalopram+omega-3 PUFAsEscitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg） |
| Escitalopram + Aripiprazole | Experimental | Drug: Escitalopram+AripiprazoleEscitalopram (10-20 mg/day）combined with Aripiprazole （2.5-10 mg/day) |
| Escitalopram + omega-3 PUFAs + Aripiprazole | Experimental | Drug: Escitalopram+Aripiprazole+omega-3 PUFAsEscitalopram (10-20 mg/day）combined with omega-3 PUFAs （EPA 900mg，DHA 300 mg）and Aripiprazole （2.5-10 mg/day) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramEscitalopram | Drug | Escitalopram |
| Escitalopram+AripiprazoleEscitalopram+Aripiprazole | Drug | Escitalopram + Aripiprazole |
| Escitalopram+omega-3 PUFAsEscitalopram+omega-3 PUFAs | Drug | Escitalopram + omega-3 PUFAs |
| Escitalopram+Aripiprazole+omega-3 PUFAsEscitalopram+Aripiprazole+omega-3 PUFAs | Drug | Escitalopram + omega-3 PUFAs + Aripiprazole |
Primary outcome
17-item Hamilton depression rating scale (HAMD-17) value
Time frame: Day 0 to Day 56
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.
Anhedonia level-Dimensional Anhedonia Rating Scale (DARS)
Time frame: Day 0 to Day 56
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.
1 secondary outcome
Anxiety symptoms
Time frame: Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Outpatients or Inpatients With Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram, Escitalopram+Aripiprazole and Escitalopram+omega-3 PUFAs in people with Outpatients / Inpatients With Depression, run by Peking University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tian-Mei Si, Ph.D (861062723748, sitianmei@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-item Hamilton depression rating scale (HAMD-17) value (time frame: Day 0 to Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.