Relapse Predicting Model for First Episode Depression

Major Depressive Disorders Clinical Trial

— RPM-FED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02942251
• Other study ID #: Pending
• Status: Not yet recruiting
• Phase: N/A
• First received: October 20, 2016
• Last updated: October 25, 2016
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Shanghai Mental Health Center
• Contact: Jun Chen, M.D., Ph.D
• Phone: 021-34773367
• Email: doctorcj2010[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D total score	The change from baseline to end of study (EOS) in HAM-D total score	12 weeks	Yes
Secondary	Time to relapse	The time to new intervention for an emerging mood episode	12 months	Yes