NCT02942251

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 20, 2016

Last Update Submit

October 25, 2016

Conditions

Major Depressive Disorders

Keywords

MDDbig data analytics

Outcome Measures

Primary Outcomes (1)

  • HAM-D total score

    The change from baseline to end of study (EOS) in HAM-D total score

    12 weeks

Secondary Outcomes (1)

  • Time to relapse

    12 months

Study Arms (6)

Clinical features and medication

EXPERIMENTAL

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

Other: Clinical features and medication

Psycho-social

EXPERIMENTAL

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

Other: Psycho-social

immunology

EXPERIMENTAL

A group patients with significant high risk of immune disturbance.

Other: immunology

Laboratory abnormality

EXPERIMENTAL

A group patients with significant high risk of Laboratory abnormalities.

Other: Laboratory abnormality

Comorbidity

EXPERIMENTAL

A group patients with physical or mental disorders comorbidities.

Other: Comorbidity

Treatment as usual

EXPERIMENTAL

Control group.

Other: Treatment as usual

Interventions

Clinical features and medicationOTHER

This group will be suggested to take optimize treatment according to Chinese treatment guidelines.

Clinical features and medication
Psycho-socialOTHER

This group will be suggested to add on psychotherapy on medical treatment.

Psycho-social
immunologyOTHER

This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.

immunology
Laboratory abnormalityOTHER

This group will be suggested to more safety antidepressants.

Laboratory abnormality
ComorbidityOTHER

This group will be suggested to treat their comorbidities as well as treat MDD.

Comorbidity
Treatment as usualOTHER

Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.

Also known as: Treatment as usual(TAU)
Treatment as usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Dosage FormsTransplantation ImmunologyComorbidityTherapeutics

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesImmune System PhenomenaEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jun Chen, M.D., Ph.D

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Chen, M.D., Ph.D

CONTACT

021-34773367doctorcj2010@gmail.com

Jia Huang, Master

CONTACT

13750892815kittyhj_2000@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 24, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

October 26, 2016

Record last verified: 2016-10