Objective Diagnostic Markers and Personalized Intervention in MDD Patients

Peking University

Status: Unknown

Conditions: Depressive Disorder, Major

Treatments: Drug: SSRIs

Study type: Interventional

Funder types: Other

Identifiers

NCT02023567

2013CB531305

Details and patient eligibility

About

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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

MDD group

Experimental group

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)

Treatment:

Drug: SSRIs

Healthy controls

No Intervention group

Description:

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