Objective Diagnostic Markers and Personalized Intervention in MDD Patients

Study Overview
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Brief Summary
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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 interactionon 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.

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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: SSRIs


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDD group<br>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<br>* 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<br>* Other names: selective serotonin reuptake inhibitors;|
| No Intervention: Healthy controls<br>This group just receive baseline evaluation and did not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of HAMD total score at 8 weeks from baseline | The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group | week 0,2,4,8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of HAMA total score at 8 weeks from baseline | The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group | week 0,2,4,8 | 
| The change of CGI score at 8 weeks from baseline | The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group | 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 |