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

Primary Purpose

Major Depressive Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical features and medication
Psycho-social
immunology
Laboratory abnormality
Comorbidity
Treatment as usual
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Depressive Disorders focused on measuring MDD, big data analytics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Clinical features and medication

    Psycho-social

    immunology

    Laboratory abnormality

    Comorbidity

    Treatment as usual

    Arm Description

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

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

    A group patients with significant high risk of immune disturbance.

    A group patients with significant high risk of Laboratory abnormalities.

    A group patients with physical or mental disorders comorbidities.

    Control group.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Time to relapse
    The time to new intervention for an emerging mood episode

    Full Information

    First Posted
    October 20, 2016
    Last Updated
    October 25, 2016
    Sponsor
    Shanghai Mental Health Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02942251
    Brief Title
    Relapse Predicting Model for First Episode Depression
    Acronym
    RPM-FED
    Official Title
    The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Mental Health Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorders
    Keywords
    MDD, big data analytics

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinical features and medication
    Arm Type
    Experimental
    Arm Description
    A group patients with significant high risk of clinical features and medications.
    Arm Title
    Psycho-social
    Arm Type
    Experimental
    Arm Description
    A group patients with significant high risk of psycho-social problems.
    Arm Title
    immunology
    Arm Type
    Experimental
    Arm Description
    A group patients with significant high risk of immune disturbance.
    Arm Title
    Laboratory abnormality
    Arm Type
    Experimental
    Arm Description
    A group patients with significant high risk of Laboratory abnormalities.
    Arm Title
    Comorbidity
    Arm Type
    Experimental
    Arm Description
    A group patients with physical or mental disorders comorbidities.
    Arm Title
    Treatment as usual
    Arm Type
    Experimental
    Arm Description
    Control group.
    Intervention Type
    Other
    Intervention Name(s)
    Clinical features and medication
    Intervention Description
    This group will be suggested to take optimize treatment according to Chinese treatment guidelines.
    Intervention Type
    Other
    Intervention Name(s)
    Psycho-social
    Intervention Description
    This group will be suggested to add on psychotherapy on medical treatment.
    Intervention Type
    Other
    Intervention Name(s)
    immunology
    Intervention Description
    This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Laboratory abnormality
    Intervention Description
    This group will be suggested to more safety antidepressants.
    Intervention Type
    Other
    Intervention Name(s)
    Comorbidity
    Intervention Description
    This group will be suggested to treat their comorbidities as well as treat MDD.
    Intervention Type
    Other
    Intervention Name(s)
    Treatment as usual
    Other Intervention Name(s)
    Treatment as usual(TAU)
    Intervention Description
    Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.
    Primary Outcome Measure Information:
    Title
    HAM-D total score
    Description
    The change from baseline to end of study (EOS) in HAM-D total score
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Time to relapse
    Description
    The time to new intervention for an emerging mood episode
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Chen, M.D., Ph.D
    Phone
    021-34773367
    Email
    doctorcj2010@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jia Huang, Master
    Phone
    13750892815
    Email
    kittyhj_2000@aliyun.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Chen, M.D., Ph.D
    Organizational Affiliation
    Shanghai Mental Health Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Relapse Predicting Model for First Episode Depression

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