Objective Diagnostic Markers and Personalized Intervention in MDD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimization of Diagnosis and Treatment of Depression Based on Multidimensional Clinical Assessment Classification

NCT04528628

Major Depressive Disorder

UNKNOWN NA

A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features

NCT04209166

Major Depressive Disorder

UNKNOWN NA

Action Tendencies and Prognosis in Major Depressive Disorder

NCT04593537

Major Depressive Disorder

COMPLETED

A Kynurenine Pathway-based Molecular Imaging Study of Individualized Diagnosis and Treatment for Major Depressive Disorder

NCT04208932

Major Depressive Disorder

UNKNOWN

Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

NCT03230682

Major Depressive Disorder

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder, Major

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

SSRIs

Intervention Type DRUG

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

Healthy controls

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SSRIs

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

selective serotonin reuptake inhibitors

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* age between 18 and 55 years at the time of enrollment;
* providing written confirmation of informed consent prior to engaging the study.

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xin Yu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xin Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Sixth Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Anding Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING