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Objective Diagnostic Markers and Personalized Intervention in MDD Patients

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ClinicalTrials.gov Identifier: NCT02023567
Recruitment Status : Unknown
Verified May 2016 by Xin Yu, Peking University.
Recruitment status was:  Recruiting
First Posted : December 30, 2013
Last Update Posted : May 20, 2016
Sponsor:
Collaborators:
Capital Medical University
Peking Union Medical College Hospital
Tianjin Medical University General Hospital
Tianjin Anding Hospital
The First Hospital of Hebei Medical University
First Hospital of China Medical University
Dalian Seventh People's Hospital
The First Affiliated Hospital of Shanxi Medical University
Information provided by (Responsible Party):
Xin Yu, Peking University

Tracking Information
First Submitted Date  ICMJE December 15, 2013
First Posted Date  ICMJE December 30, 2013
Last Update Posted Date May 20, 2016
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
The changes of HAMD total score at 8 weeks from baseline [ Time Frame: week 0,2,4,8 ]
The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
The changes of HAMD total score at 8 weeks from baseline [ Time Frame: 8 weeks or the course of 8 times' Modified Electraconvulsive therapy (MECT) ]
The scores are assessed at 0,2,4,8 weeks since the medication begins for medication intervention groups, while the scores are assessed at 0, first, fourth, eighth MECT
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
  • The changes of HAMA total score at 8 weeks from baseline [ Time Frame: week 0,2,4,8 ]
    The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
  • The change of CGI score at 8 weeks from baseline [ Time Frame: week 0,2,4,8 ]
    The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
  • The prognosis after the intervention [ Time Frame: Up to 2 years ]
  • Number of participants with serious and non-serious adverse events [ Time Frame: Up to two years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • The changes of HAMA total score at 8 weeks from baseline [ Time Frame: 8 weeks or the course of 8 times' MECT ]
    The scores are assessment at 0,2,4,8 weeks since the medication begins for medication intervention groups and at 0, first, fourth, eighth MECT
  • The change of CGI score at 8 weeks from baseline [ Time Frame: 8 weeks or the course of 8 times' MECT ]
    The scores are assessment at 0,2,4,8 weeks since the medication begins for medication intervention groups and at 0, first, fourth, eighth MECT
  • The change of YMRS total score at 8 weeks from baseline [ Time Frame: 8 weeks or the course of 8 times' MECT ]
    The scores are assessment at 0,2,4,8 weeks since the medication begins for medication intervention groups and at 0, first, fourth, eighth MECT
  • The remission rate after the intervention [ Time Frame: Up to 2 years ]
  • Number of participants with serious and non-serious adverse events [ Time Frame: Up to two years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Objective Diagnostic Markers and Personalized Intervention in MDD Patients
Official Title  ICMJE The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)
Brief Summary Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It's assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of MDD for classifying MDD into "genetic type", "environmental type" and "others" based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE Drug: SSRIs
fluoxertine hydrochloride 20-60mg/day, paroxetine hydrochloride 20-60mg/day, sertraline hydrochloride 50-200mg/day, citalopram 20-60mg/day, escitalopram 10-20mg/day, fluvoxamine 50-300mg/day
Other Name: selective serotonin reuptake inhibitors
Study Arms  ICMJE
  • Experimental: MDD group
    Drugs: SSRIs fluoxertine hydrochloride (20- 60m/day),paroxetine hydrochloride (20- 60m/day),sertraline hydrochloride (50- 200m/day),citalopram (20-60m/day), escitalopram (10-20mg/day),fluvoxamine (50-300mg/day)
    Intervention: Drug: SSRIs
  • No Intervention: Healthy controls
    This group just receive baseline evaluation and did not receive any intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 18, 2016)
2400
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2013)
2700
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  1. For MDD group:

    Inclusion criteria:

    • Age between 18-55, male or female;
    • The diagnosis of MDD consistent with DSM-IV (M.I.N.I)
    • First-episode or relapsed;
    • Certain ability of reading and writing to complete the questionnaire survey and psychological assessment.
    • All participants provide written confirmation of informed consent prior to engaging the study protocol.

    Exclusion criteria:

    • Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment;
    • Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
    • Not signed the informed consent;
    • Been engaging other studies.
  2. For Healthy control group

Inclusion criteria:

  • age between 18 and 55 years at the time of enrollment;
  • providing written confirmation of informed consent prior to engaging the study.

Exclusion criteria:

  • lifetime or current diagnosis of any mental diseases;
  • severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
  • not signed the informed consent;
  • been engaging other studies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02023567
Other Study ID Numbers  ICMJE 2013CB531305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: After enrollment completion,we will decided whether share data or not.
Responsible Party Xin Yu, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE
  • Capital Medical University
  • Peking Union Medical College Hospital
  • Tianjin Medical University General Hospital
  • Tianjin Anding Hospital
  • The First Hospital of Hebei Medical University
  • First Hospital of China Medical University
  • Dalian Seventh People's Hospital
  • The First Affiliated Hospital of Shanxi Medical University
Investigators  ICMJE
Principal Investigator: Xin Yu, MD Peking University Sixth Hospital
PRS Account Peking University
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP