Objective Diagnostic Markers and Personalized Intervention in MDD Patients

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02023567
• Other study ID #: 2013CB531305
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2013
• Last updated: May 18, 2016
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Peking University
• Contact: Tianmei Si, MD
• Phone: 86-10-62723748
• Email: si.tian-mei[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Anding Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Dalian Seventh People's Hospital	Dalian	Liaoning
China	First Hospital of China Medical University	Shenyang	Liaoning
China	Hebei Medical University First Hospital	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Anding Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (9)

Lead Sponsor	Collaborator
Peking University	Capital Medical University, Dalian Seventh People's Hospital, First Hospita of Shanxi Medical University, First Hospital of China Medical University, Hebei Medical University First Hospital, Peking Union Medical College Hospital, Tianjin Anding Hospital, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	The prognosis after the intervention		Up to 2 years	No
Secondary	Number of participants with serious and non-serious adverse events		Up to two years	Yes