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

Shanghai Mental Health Center

Status: Unknown

Conditions: Major Depressive Disorders

Treatments: Other: immunology; Other: Laboratory abnormality; Other: Comorbidity; Other: Clinical features and medication; Other: Treatment as usual; Other: Psycho-social

Study type: Interventional

Funder types: Other

Identifiers

NCT02942251

Pending

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 6 patient groups

Clinical features and medication

Experimental group

Description:

A group patients with significant high risk of clinical features and medications.

Treatment:

Other: Clinical features and medication

Psycho-social

Experimental group

Description:

A group patients with significant high risk of psycho-social problems.

Treatment:

Other: Psycho-social

immunology

Experimental group

Description:

A group patients with significant high risk of immune disturbance.

Treatment:

Other: immunology

Laboratory abnormality

Experimental group

Description:

A group patients with significant high risk of Laboratory abnormalities.

Treatment:

Other: Laboratory abnormality

Comorbidity

Experimental group

Description:

A group patients with physical or mental disorders comorbidities.

Treatment:

Other: Comorbidity

Treatment as usual

Experimental group

Description:

Control group.

Treatment:

Other: Treatment as usual