Objective Diagnostic Markers and Personalized Intervention in MDD Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| 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 Names:
|
| No Intervention: Healthy controls This group just receive baseline evaluation and did not receive any intervention. |
Outcome Measures
Primary Outcome Measures
- The changes of HAMD total score at 8 weeks from baseline [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
- The changes of HAMA total score at 8 weeks from baseline [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 [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 [Up to 2 years]
- Number of participants with serious and non-serious adverse events [Up to two years]
Eligibility Criteria
Criteria
- For MDD group:
Inclusion criteria:
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Age between 18-55, male or female;
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The diagnosis of MDD consistent with DSM-IV (M.I.N.I)
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First-episode or relapsed;
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Certain ability of reading and writing to complete the questionnaire survey and psychological assessment.
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All participants provide written confirmation of informed consent prior to engaging the study protocol.
Exclusion criteria:
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Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment;
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Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
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Not signed the informed consent;
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Been engaging other studies.
- For Healthy control group
Inclusion criteria:
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age between 18 and 55 years at the time of enrollment;
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providing written confirmation of informed consent prior to engaging the study.
Exclusion criteria:
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lifetime or current diagnosis of any mental diseases;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anding Hospital | Beijing | Beijing | China | |
| 2 | Peking Union Medical College Hospital | Beijing | Beijing | China | |
| 3 | Peking University Sixth Hospital | Beijing | Beijing | China | |
| 4 | Hebei Medical University First Hospital | Shijiazhuang | Hebei | China | |
| 5 | Dalian Seventh People's Hospital | Dalian | Liaoning | China | |
| 6 | First Hospital of China Medical University | Shenyang | Liaoning | China | |
| 7 | First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China | |
| 8 | Tianjin Anding Hospital | Tianjin | Tianjin | China | |
| 9 | Tianjin Medical University General Hospital | 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
- Principal Investigator: Xin Yu, MD, Peking University Sixth Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013CB531305