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Objective Diagnostic Markers and Personalized Intervention in MDD Patients

Primary Purpose

Depressive Disorder, Major

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SSRIs
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers
  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.

Sites / Locations

  • Beijing Anding HospitalRecruiting
  • Peking Union Medical College Hospital
  • Peking University Sixth HospitalRecruiting
  • Hebei Medical University First Hospital
  • Dalian Seventh People's Hospital
  • First Hospital of China Medical University
  • First Hospital of Shanxi Medical University
  • Tianjin Anding Hospital
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MDD group

Healthy controls

Arm Description

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)

This group just receive baseline evaluation and did not receive any intervention.

Outcomes

Primary Outcome Measures

The changes of HAMD total score at 8 weeks from baseline
The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group

Secondary Outcome Measures

The changes of HAMA total score at 8 weeks from baseline
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
The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
The prognosis after the intervention
Number of participants with serious and non-serious adverse events

Full Information

First Posted
December 15, 2013
Last Updated
May 18, 2016
Sponsor
Peking University
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
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1. Study Identification

Unique Protocol Identification Number
NCT02023567
Brief Title
Objective Diagnostic Markers and Personalized Intervention in MDD Patients
Official Title
The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MDD group
Arm Type
Experimental
Arm Description
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)
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
This group just receive baseline evaluation and did not receive any intervention.
Intervention Type
Drug
Intervention Name(s)
SSRIs
Other Intervention Name(s)
selective serotonin reuptake inhibitors
Intervention Description
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
Primary Outcome Measure Information:
Title
The changes of HAMD total score at 8 weeks from baseline
Description
The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group
Time Frame
week 0,2,4,8
Secondary Outcome Measure Information:
Title
The changes of HAMA total score at 8 weeks from baseline
Description
The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
Time Frame
week 0,2,4,8
Title
The change of CGI score at 8 weeks from baseline
Description
The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
Time Frame
week 0,2,4,8
Title
The prognosis after the intervention
Time Frame
Up to 2 years
Title
Number of participants with serious and non-serious adverse events
Time Frame
Up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tianmei Si, MD
Phone
86-10-62723748
Ext
86-139109877
Email
si.tian-mei@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Wang, MD
Email
gangwangdoc@mail1.bbuser.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Yu, MD
Organizational Affiliation
Peking University Sixth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Wang
Phone
86-13911695727
Email
gangwangdoc@gmail.com
First Name & Middle Initial & Last Name & Degree
Changqing Hu
Phone
86-13661106500
Email
coannhu@126.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Liu
Phone
86-10-82801955
Ext
86-13671013073
Email
liu_qee@sina.com
Facility Name
Hebei Medical University First Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Dalian Seventh People's Hospital
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
After enrollment completion,we will decided whether share data or not.
Citations:
PubMed Identifier
34985583
Citation
Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yan H, Wang Y, Yu X, Si T. Childhood adversity, adulthood adversity and suicidal ideation in Chinese patients with major depressive disorder: in line with stress sensitization. Eur Arch Psychiatry Clin Neurosci. 2022 Aug;272(5):887-896. doi: 10.1007/s00406-021-01375-4. Epub 2022 Jan 5.
Results Reference
derived
PubMed Identifier
33874911
Citation
Cui F, Liu Q, Lv X, Leonhart R, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Severe sleep disturbance is associated with executive function impairment in patients with first-episode, treatment-naive major depressive disorders. BMC Psychiatry. 2021 Apr 19;21(1):198. doi: 10.1186/s12888-021-03194-2.
Results Reference
derived
PubMed Identifier
31959583
Citation
Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Wang Y, Yu X, Si T. Perceived stressfulness mediates the effects of subjective social support and negative coping style on suicide risk in Chinese patients with major depressive disorder. J Affect Disord. 2020 Mar 15;265:32-38. doi: 10.1016/j.jad.2020.01.026. Epub 2020 Jan 10.
Results Reference
derived
PubMed Identifier
29664050
Citation
Lin JY, Huang Y, Su YA, Yu X, Lyu XZ, Liu Q, Si TM. Association between Perceived Stressfulness of Stressful Life Events and the Suicidal Risk in Chinese Patients with Major Depressive Disorder. Chin Med J (Engl). 2018 Apr 20;131(8):912-919. doi: 10.4103/0366-6999.229898.
Results Reference
derived
PubMed Identifier
27422150
Citation
Lv X, Si T, Wang G, Wang H, Liu Q, Hu C, Wang J, Su Y, Huang Y, Jiang H, Yu X. The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol. BMC Psychiatry. 2016 Jul 15;16:240. doi: 10.1186/s12888-016-0953-z.
Results Reference
derived

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Objective Diagnostic Markers and Personalized Intervention in MDD Patients

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