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Clinical Trials/NCT02023567
NCT02023567
Unknown
Not Applicable

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

Peking University9 sites in 1 country2,400 target enrollmentNovember 2013
InterventionsSSRIs
DrugsSSRIs

Overview

Phase
Not Applicable
Intervention
SSRIs
Conditions
Depressive Disorder, Major
Sponsor
Peking University
Enrollment
2400
Locations
9
Primary Endpoint
The changes of HAMD total score at 8 weeks from baseline
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peking University
Responsible Party
Principal Investigator
Principal Investigator

Xin Yu

Professor

Peking University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

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: SSRIs

Outcomes

Primary Outcomes

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 Outcomes

  • The change of CGI score at 8 weeks from baseline(week 0,2,4,8)
  • The prognosis after the intervention(Up to 2 years)
  • Number of participants with serious and non-serious adverse events(Up to two years)
  • The changes of HAMA total score at 8 weeks from baseline(week 0,2,4,8)

Study Sites (9)

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