An observational study in Affective Disorder, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by Peking University · Observational
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.
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.
Patients with major depressive disorder
Exclusion Criteria:
Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.
Drug: Escitalopram Pill
Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.
Drug: Duloxetine
Eligible patients were assigned to mirtazepine treatment based on investigators' clinical practice.
Drug: Mirtazapine Pill
Eligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice.
Drug: Other Antidepressants
escitalopram 10\~20mg/day
Also known as: Lexapro
duloxetine 30\~120mg/day
Also known as: Cymbalta
Mirtazapine 15\~45mg/day
Also known as: Remeron
reduction in HAMD total scores
reduction more than 50% was regarded as response
Time frame: 8 weeks
remision
HAMD total score less than 7
Time frame: 8 weeks
Plan to share: No
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Peking University