Objective Diagnostic Markers and Personalized Intervention in MDD Patients

Not Applicable

• Conditions: Depressive Disorder, Major
• Interventions: Drug: SSRIs

• Registration Number: NCT02023567
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-15
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-20
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDD group	SSRIs	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (9)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Hebei Medical University First Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Peking University Sixth Hospital; 🇨🇳 Beijing, Beijing, China

Dalian Seventh People's Hospital; 🇨🇳 Dalian, Liaoning, China

Tianjin Anding Hospital; 🇨🇳 Tianjin, Tianjin, China

Beijing Anding Hospital; 🇨🇳 Beijing, Beijing, China

First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China