Relapse Predicting Model for First Episode Depression

Not Applicable

• Conditions: Major Depressive Disorders
• Interventions: Other: Comorbidity; Other: Psycho-social; Other: Laboratory abnormality; Other: immunology; Other: Treatment as usual; Other: Clinical features and medication

• Registration Number: NCT02942251
• Lead Sponsor: Shanghai Mental Health Center

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 Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-24
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comorbidity	Comorbidity	A group patients with physical or mental disorders comorbidities.
Psycho-social	Psycho-social	A group patients with significant high risk of psycho-social problems.
Laboratory abnormality	Laboratory abnormality	A group patients with significant high risk of Laboratory abnormalities.
immunology	immunology	A group patients with significant high risk of immune disturbance.
Treatment as usual	Treatment as usual	Control group.
Clinical features and medication	Clinical features and medication	A group patients with significant high risk of clinical features and medications.

Primary Outcome Measures

Name	Time	Method
HAM-D total score	12 weeks	The change from baseline to end of study (EOS) in HAM-D total score

Secondary Outcome Measures

Name	Time	Method
Time to relapse	12 months	The time to new intervention for an emerging mood episode