NCT03294525

Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

Clinical Psychopharmacology Division

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Affective Disorder

Interventions

Type	Name	Description
DRUG	Escitalopram Pill	escitalopram 10\~20mg/day
DRUG	Duloxetine	duloxetine 30\~120mg/day
DRUG	Mirtazapine Pill	Mirtazapine 15\~45mg/day
DRUG	Other Antidepressants

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-12-01
• Completion: 2022-08-01
• First posted: 2017-09-27
• Last updated: 2021-08-30

Locations

1 site across 1 country: China