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The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)

Information source: Peking University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: SSIRs (Drug); Modified Electraconvulsive therapy (MECT) (Procedure)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Peking University

Official(s) and/or principal investigator(s):
Xin Yu, MD, Principal Investigator, Affiliation: Peking University 6th Hospital

Overall contact:
Tianmei Si, MD, Email: Si.tian-mei@163.com

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, electrophysiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of different MDD subtypes. The investigators further analyse the changes of these indicators after 8 weeks'medication or 8 times' MECT to select the potential predictors for therapeutic evaluations and interventional options in different subtype MDD. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in different subtype MDD.

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: The changes of HAMD total score at 8 weeks from baseline

Secondary outcome:

The changes of HAMA total score at 8 weeks from baseline

The change of CGI score at 8 weeks from baseline

The change of YMRS total score at 8 weeks from baseline

The remission rate after the intervention

Number of participants with serious and non-serious adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Tianmei Si, MD, Email: Si.tian-mei@163.com

Additional Information

Starting date: January 2014
Last updated: December 23, 2013

Page last updated: August 23, 2015

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