Relapse Predicting Model for First Episode Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry

Conditions
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Major Depressive Disorders

Intervention / Treatment
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* Other: Clinical features and medication
* Other: Psycho-social
* Other: immunology
* Other: Laboratory abnormality
* Other: Comorbidity
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical features and medication<br>A group patients with significant high risk of clinical features and medications. | Other: Clinical features and medication<br>* This group will be suggested to take optimize treatment according to Chinese treatment guidelines.<br>|
| Experimental: Psycho-social<br>A group patients with significant high risk of psycho-social problems. | Other: Psycho-social<br>* This group will be suggested to add on psychotherapy on medical treatment.<br>|
| Experimental: immunology<br>A group patients with significant high risk of immune disturbance. | Other: immunology<br>* This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.<br>|
| Experimental: Laboratory abnormality<br>A group patients with significant high risk of Laboratory abnormalities. | Other: Laboratory abnormality<br>* This group will be suggested to more safety antidepressants.<br>|
| Experimental: Comorbidity<br>A group patients with physical or mental disorders comorbidities. | Other: Comorbidity<br>* This group will be suggested to treat their comorbidities as well as treat MDD.<br>|
| Experimental: Treatment as usual<br>Control group. | Other: Treatment as usual<br>* Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.<br>* Other names: Treatment as usual(TAU);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D total score | The change from baseline to end of study (EOS) in HAM-D total score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse | The time to new intervention for an emerging mood episode | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD, big data analytics