Relapse Predicting Model for First Episode Depression (RPM-FED)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: MDD; big data analytics
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: Pending (ICTR award)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED