The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 300
- Primary Endpoint
- HAM-D total score
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Clinical features and medication
A group patients with significant high risk of clinical features and medications.
Intervention: Clinical features and medication (Other)
Psycho-social
A group patients with significant high risk of psycho-social problems.
Intervention: Psycho-social (Other)
immunology
A group patients with significant high risk of immune disturbance.
Intervention: immunology (Other)
Laboratory abnormality
A group patients with significant high risk of Laboratory abnormalities.
Intervention: Laboratory abnormality (Other)
Comorbidity
A group patients with physical or mental disorders comorbidities.
Intervention: Comorbidity (Other)
Treatment as usual
Control group.
Intervention: Treatment as usual (Other)
Outcomes
Primary Outcomes
HAM-D total score
Time Frame: 12 weeks
The change from baseline to end of study (EOS) in HAM-D total score
Secondary Outcomes
- Time to relapse(12 months)