Major Depressive DisordersRPM-FEDNCT02942251
Relapse Predicting Model for First Episode Depression
A study testing Clinical features and medication, Psycho-social and immunology in people with Major Depressive Disorders, run by Shanghai Mental Health Center.
Trial summary
Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorders
- What is being tested?
- Clinical features and medication, Psycho-social and immunology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old;
- Han Chinese;
- Outpatient and inpatient patients;
- Patients met Diagnostic and Statistical Manual of Mental Disorders(DSM-IV-TR) criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
- Hamilton Depression Scale(HAM-D) total score≥17, HAM-D item 1 (depressed mood) score≥2, and Young Mania Rating Scale(YMRS) total score≤10 at baseline;
- Written informed consent was given;
- Junior high school education and above, with enough audio-visual ability to accomplish the visits;
- Normally resident in one country and had a residential address, able to follow-up.
Who cannot join
- Bipolar disorder rapid cycling or mixed episode;
- Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
- Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
- Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
- Female patients who were pregnant, planning to be pregnant or breast feeding;
- Severe medical or neurological problems.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry
Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.
Read the detailed description
Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.
This study includes two steps. Step 1: Big data analysis based on the clinical features and immunochemical figures of 30000 patients with first episode MDD will be conducted to construct a relapse predict model.
Step 2: 300 patients with first episode MDD will be recruited in this step. Physicians prefer to give corresponding treatment recommendation based on the predictive factors to verify this relapse model.
- Conditions
- Major Depressive Disorders
- Being tested
- Clinical features and medication, Psycho-social, immunology, Laboratory abnormality, Comorbidity
- Keywords
- MDD, big data analytics
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical features and medicationOther
This group will be suggested to take optimize treatment according to Chinese treatment guidelines.
Psycho-socialOther
This group will be suggested to add on psychotherapy on medical treatment.
immunologyOther
This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.
Laboratory abnormalityOther
This group will be suggested to more safety antidepressants.
ComorbidityOther
This group will be suggested to treat their comorbidities as well as treat MDD.
Treatment as usualOther
Also called Treatment as usual(TAU)
Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.
| Study group | Role | What they receive |
|---|---|---|
| Clinical features and medication | Experimental | A group patients with significant high risk of clinical features and medications. Receives: Other: Clinical features and medication |
| Psycho-social | Experimental | A group patients with significant high risk of psycho-social problems. Receives: Other: Psycho-social |
| immunology | Experimental | A group patients with significant high risk of immune disturbance. Receives: Other: immunology |
| Laboratory abnormality | Experimental | A group patients with significant high risk of Laboratory abnormalities. Receives: Other: Laboratory abnormality |
| Comorbidity | Experimental | A group patients with physical or mental disorders comorbidities. Receives: Other: Comorbidity |
| Treatment as usual | Experimental | Control group. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D total score
The change from baseline to end of study (EOS) in HAM-D total score
Measured: 12 weeks
Secondary outcomes (1)
Time to relapse
The time to new intervention for an emerging mood episode
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisordersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Chen, M.D., Ph.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942251
- Sponsor's protocol ID
- Pending
- Acronym
- RPM-FED
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry
- ClinicalTrials.gov ID
- NCT02942251
- Acronym / sponsor ID
- RPM-FED / Pending
- Conditions
- Major Depressive Disorders
- Keywords
- MDD, big data analytics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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.
Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.
Detailed description
Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.
This study includes two steps. Step 1: Big data analysis based on the clinical features and immunochemical figures of 30000 patients with first episode MDD will be conducted to construct a relapse predict model.
Step 2: 300 patients with first episode MDD will be recruited in this step. Physicians prefer to give corresponding treatment recommendation based on the predictive factors to verify this relapse model.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Clinical features and medication | Experimental | Other: Clinical features and medicationA group patients with significant high risk of clinical features and medications. |
| Psycho-social | Experimental | Other: Psycho-socialA group patients with significant high risk of psycho-social problems. |
| immunology | Experimental | Other: immunologyA group patients with significant high risk of immune disturbance. |
| Laboratory abnormality | Experimental | Other: Laboratory abnormalityA group patients with significant high risk of Laboratory abnormalities. |
| Comorbidity | Experimental | Other: ComorbidityA group patients with physical or mental disorders comorbidities. |
| Treatment as usual | Experimental | Other: Treatment as usualControl group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age from 18 to 65 years old;
- Han Chinese;
- Outpatient and inpatient patients;
- Patients met Diagnostic and Statistical Manual of Mental Disorders(DSM-IV-TR) criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
- Hamilton Depression Scale(HAM-D) total score≥17, HAM-D item 1 (depressed mood) score≥2, and Young Mania Rating Scale(YMRS) total score≤10 at baseline;
Key exclusion criteria (6 listed)
- Bipolar disorder rapid cycling or mixed episode;
- Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
- Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
- Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
- Female patients who were pregnant, planning to be pregnant or breast feeding;
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 |
|---|---|---|
| Clinical features and medicationThis group will be suggested to take optimize treatment according to Chinese treatment guidelines. | Other | Clinical features and medication |
| Psycho-socialThis group will be suggested to add on psychotherapy on medical treatment. | Other | Psycho-social |
| immunologyThis group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment. | Other | immunology |
| Laboratory abnormalityThis group will be suggested to more safety antidepressants. | Other | Laboratory abnormality |
| ComorbidityThis group will be suggested to treat their comorbidities as well as treat MDD. | Other | Comorbidity |
| Treatment as usualAlso: Treatment as usual(TAU)Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model. | Other | Treatment as usual |
Primary outcome
HAM-D total score
Time frame: 12 weeks
The change from baseline to end of study (EOS) in HAM-D total score
1 secondary outcome
Time to relapse
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jun Chen, M.D., Ph.D principal investigator
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
A study testing Clinical features and medication, Psycho-social and immunology in people with Major Depressive Disorders, run by Shanghai Mental Health Center.
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 8 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 26 Oct 2016. 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.
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 Jun Chen, M.D., Ph.D (021-34773367, doctorcj2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAM-D total score (time frame: 12 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 26 Oct 2016; AzTrials last refreshed its copy on 27 Oct 2026.