Skip to content

Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

Clinical Psychopharmacology Division

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03294525
Enrollment
400
Registered
2017-09-27
Start date
2016-01-31
Completion date
2022-08-31
Last updated
2021-08-30

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

Conditions

Affective Disorder

Brief 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.

Interventions

escitalopram 10\ 20mg/day

DRUGDuloxetine

duloxetine 30\ 120mg/day

DRUGMirtazapine Pill

Mirtazapine 15\ 45mg/day

DRUGOther Antidepressants

Sponsors

Peking University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

1\. Patients with depression * The inclusion criteria for depressed patients were: male or female outpatients aged between 18 and 55 years old * Currently in acute depressive episode * Total HAMD-17 score≥14 at baseline visit. * The diagnosis of depression was confirmed by a trained psychiatrists using the Mini-International Neuropsychiatric Interview (MINI). * The patients participating in imaging scans should additionally satisfy: not taking psychiatric drugs within last two weeks (except for benzodiazepine) or fluoxetine last one month * Not receiving ECT within last 6 months.

Exclusion criteria

* Unable to complete the questionnaire and psychological assessment independently * Significant cognitive impairments determined by system mental examination and inability to sign an informed consent form * Past or presently suffering from other psychiatric disorders, alcohol and drug dependence * Suffering from major physical diseases, such as cardiovascular and cerebrovascular diseases, respiratory diseases, kidney disease, cancer and so on; personality disorder * Intellectual disabilities * Suicidal behavior * Being participating in other studies.

Design outcomes

Primary

MeasureTime frameDescription
reduction in HAMD total scores8 weeksreduction more than 50% was regarded as response
remision8 weeksHAMD total score less than 7

Countries

China

Contacts

Primary ContactYunai Su, PhD
suyunai@163.com010-62723761

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026