Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03294525 |
Other study ID # |
001 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 2016 |
Est. completion date |
August 2022 |
Study information
Verified date |
August 2021 |
Source |
Peking University |
Contact |
Yunai Su, PhD |
Phone |
010-62723761 |
Email |
suyunai[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The project is a multi-center, prospective cohort study. The study's total targeted
enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy
controls.
Description:
Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥14 at
baseline visit are to be assigned to one of the second-generation antidepressant drugs,
including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on
investigators' clinical practice. Initial treatment consists of a 8-week course with one of
these monotherapies. Patients who meet criteria for full remission are followed for a
22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are
offered another 8 weeks of acute treatment, including combination therapy or switching to
other antidepressant based on investigators' clinical practice. The clinical assessment
(Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and
Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale
(DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI,
genetics, neurochemistry, and immunology) were conducted to identify the biomarkers
associated with diagnosis, treatment efficacy prediction of depression. Among the 400
patients, about 100 patients receive MRI scans at baseline and after treatment.