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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

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: SSRIs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)
Study Start Date : November 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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

No Intervention: Healthy controls
This group just receive baseline evaluation and did not receive any intervention.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. The prognosis after the intervention [ Time Frame: Up to 2 years ]
  4. Number of participants with serious and non-serious adverse events [ Time Frame: Up to two years ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023567


Contacts
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Contact: Tianmei Si, MD 86-10-62723748 ext 86-139109877 si.tian-mei@163.com
Contact: Gang Wang, MD gangwangdoc@mail1.bbuser.com

Locations
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China, Beijing
Beijing Anding Hospital Recruiting
Beijing, Beijing, China
Contact: Gang Wang    86-13911695727    gangwangdoc@gmail.com   
Contact: Changqing Hu    86-13661106500    coannhu@126.com   
Peking Union Medical College Hospital Active, not recruiting
Beijing, Beijing, China
Peking University Sixth Hospital Recruiting
Beijing, Beijing, China
Contact: Qi Liu    86-10-82801955 ext 86-13671013073    liu_qee@sina.com   
China, Hebei
Hebei Medical University First Hospital Active, not recruiting
Shijiazhuang, Hebei, China
China, Liaoning
Dalian Seventh People's Hospital Active, not recruiting
Dalian, Liaoning, China
First Hospital of China Medical University Active, not recruiting
Shenyang, Liaoning, China
China, Shanxi
First Hospital of Shanxi Medical University Active, not recruiting
Taiyuan, Shanxi, China
China, Tianjin
Tianjin Anding Hospital Active, not recruiting
Tianjin, Tianjin, China
Tianjin Medical University General Hospital Active, not recruiting
Tianjin, Tianjin, China
Sponsors and Collaborators
Peking University
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
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Principal Investigator: Xin Yu, MD Peking University Sixth Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xin Yu, Professor, Peking University
ClinicalTrials.gov Identifier: NCT02023567     History of Changes
Other Study ID Numbers: 2013CB531305
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After enrollment completion,we will decided whether share data or not.

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Sertraline
Paroxetine
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors