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Objective Diagnostic Markers and Personalized Intervention in MDD Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02023567
Enrollment
2400
Registered
2013-12-30
Start date
2013-11-30
Completion date
2016-12-31
Last updated
2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

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 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.

Interventions

DRUGSSRIs

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

Sponsors

Capital Medical University
CollaboratorOTHER
Peking Union Medical College Hospital
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
Tianjin Anding Hospital
CollaboratorOTHER
The First Hospital of Hebei Medical University
CollaboratorOTHER
First Hospital of China Medical University
CollaboratorOTHER
Dalian Seventh People's Hospital
CollaboratorOTHER
The First Affiliated Hospital of Shanxi Medical University
CollaboratorOTHER
Peking University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
The changes of HAMD total score at 8 weeks from baselineweek 0,2,4,8The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group

Secondary

MeasureTime frameDescription
The changes of HAMA total score at 8 weeks from baselineweek 0,2,4,8The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
The change of CGI score at 8 weeks from baselineweek 0,2,4,8The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
The prognosis after the interventionUp to 2 years
Number of participants with serious and non-serious adverse eventsUp to two years

Countries

China

Contacts

Primary ContactTianmei Si, MD
si.tian-mei@163.com86-10-62723748
Backup ContactGang Wang, MD
gangwangdoc@mail1.bbuser.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 13, 2026