Diagnosis and Treatment of DepressionPhase 4NCT03148509
A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway
A Phase 4 study testing risperidone, aripiprazole and bupropion in people with Diagnosis and Treatment of Depression, run by Peking University.
Trial summary
This study will recruit depressed patients unresponsive to selective serotonin reuptake inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnosis and Treatment of Depression
- What is being tested?
- risperidone, aripiprazole and bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 30 Dec 2019
- Phase
- Phase 4
- 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients unresponsive to SSRI antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls
Who cannot join
- Major physical illness; other DSM-IV axis I mental illness; personality disorder, mental retardation; drug and/or alcohol dependence; pregnant or lactating women; MRI examination contraindications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Psychopharmacology Division Institute of Mental Health, Peking University
This study will recruit depressed patients unresponsive to selective serotonin reuptake inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls. The subjects need to complete the brain positron emission tomography/magnetic resonance examination, stress assessment, genetic testing, clinical evaluation and neuropsychological tests. Using the data, this study aimed to identify the abnormalities of reward circuit of depression and its differences with other diseases, and its abnormalities in first-degree relatives of depression. The depressed patients who were ineffective in treatment with selective serotonin reuptake inhibitor antidepressants were then given combined medication with dopamine receptor-mediated drugs, including dopamine transporter inhibitor - bupropion, D2 receptor antagonist - risperidone, or D2 receptor partial agonist - aripiprazole, to examine the regulation of dopamine pathway and its relationship with the therapeutic effect. Through the above work, we will provide new evidence for integrating the biological evidence of dopamine reward pathway into the clinical practice of depression.
- Conditions
- Diagnosis and Treatment of Depression
- Being tested
- risperidone, aripiprazole, bupropion
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
DA receptor-mediated drugs
aripiprazoleDrug
DA receptor-mediated drugs
bupropionDrug
DA receptor-mediated drugs
| Study group | Role | What they receive |
|---|---|---|
| bupropion | Experimental | receive bupropion Receives: Drug: risperidone |
| risperidone | Experimental | receive risperidone Receives: Drug: aripiprazole |
| aripiprazole | Experimental | receive aripiprazole Receives: Drug: bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis and Treatment of 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148509
- Sponsor's protocol ID
- Z171100000117016
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 12 May 2017
- 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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Psychopharmacology Division Institute of Mental Health, Peking University
- ClinicalTrials.gov ID
- NCT03148509
- Acronym / sponsor ID
- Z171100000117016
- Conditions
- Diagnosis and Treatment of Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 11 May 2017 (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 will recruit depressed patients unresponsive to selective serotonin reuptake inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls. The subjects need to complete the brain positron emission tomography/magnetic resonance examination, stress assessment, genetic testing, clinical evaluation and neuropsychological tests. Using the data, this study aimed to identify the abnormalities of reward circuit of depression and its differences with other diseases, and its abnormalities in first-degree relatives of depression. The depressed patients who were ineffective in treatment with selective serotonin reuptake inhibitor antidepressants were then given combined medication with dopamine receptor-mediated drugs, including dopamine transporter inhibitor - bupropion, D2 receptor antagonist - risperidone, or D2 receptor partial agonist - aripiprazole, to examine the regulation of dopamine pathway and its relationship with the therapeutic effect. Through the above work, we will provide new evidence for integrating the biological evidence of dopamine reward pathway into the clinical practice of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupropion | Experimental | Drug: risperidonereceive bupropion |
| risperidone | Experimental | Drug: aripiprazolereceive risperidone |
| aripiprazole | Experimental | Drug: bupropionreceive aripiprazole |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients unresponsive to SSRI antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls
Key exclusion criteria (1 listed)
- Major physical illness; other DSM-IV axis I mental illness; personality disorder, mental retardation; drug and/or alcohol dependence; pregnant or lactating women; MRI examination 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 |
|---|---|---|
| risperidoneDA receptor-mediated drugs | Drug | bupropion |
| aripiprazoleDA receptor-mediated drugs | Drug | risperidone |
| bupropionDA receptor-mediated drugs | Drug | aripiprazole |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone, aripiprazole and bupropion in people with Diagnosis and Treatment of Depression, run by Peking University.
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 1 inclusion and 1 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ji-Tao Li, MD (010-62723742, ljt_102124@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (time frame: 8 weeks). 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 12 May 2017.