Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2016-12-31
2019-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Clinical features and medication
A group patients with significant high risk of clinical features and medications.
Clinical features and medication
This group will be suggested to take optimize treatment according to Chinese treatment guidelines.
Psycho-social
A group patients with significant high risk of psycho-social problems.
Psycho-social
This group will be suggested to add on psychotherapy on medical treatment.
immunology
A group patients with significant high risk of immune disturbance.
immunology
This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.
Laboratory abnormality
A group patients with significant high risk of Laboratory abnormalities.
Laboratory abnormality
This group will be suggested to more safety antidepressants.
Comorbidity
A group patients with physical or mental disorders comorbidities.
Comorbidity
This group will be suggested to treat their comorbidities as well as treat MDD.
Treatment as usual
Control group.
Treatment as usual
Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.
Interventions
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Clinical features and medication
This group will be suggested to take optimize treatment according to Chinese treatment guidelines.
Psycho-social
This group will be suggested to add on psychotherapy on medical treatment.
immunology
This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.
Laboratory abnormality
This group will be suggested to more safety antidepressants.
Comorbidity
This group will be suggested to treat their comorbidities as well as treat MDD.
Treatment as usual
Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Jun Chen, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Central Contacts
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Other Identifiers
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Pending
Identifier Type: -
Identifier Source: org_study_id