Clinical trial NCT03294525: Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders
Official title: Clinical Psychopharmacology Division
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Affective Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with major depressive 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.

Eligibility criteria: 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.

Primary outcomes:
measure: reduction in HAMD total scores
timeFrame: 8 weeks
measure: remision
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of mental health, Peking University
state: Beijing
Study officials:
affiliation: Sixth hospital of beijing university
name: Tianmei Si, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin J, Su Y, Rizvi SJ, Jagoda J, Li J, Wu Y, Dai Y, Zhang Y, Kennedy SH, Si T. Define and characterize the anhedonia in major depressive disorder: An explorative study. J Affect Disord. 2022 Sep 15;313:235-242. doi: 10.1016/j.jad.2022.06.082. Epub 2022 Jul 3.
citation: Li L, Su YA, Wu YK, Castellanos FX, Li K, Li JT, Si TM, Yan CG. Eight-week antidepressant treatment reduces functional connectivity in first-episode drug-naive patients with major depressive disorder. Hum Brain Mapp. 2021 Jun 1;42(8):2593-2605. doi: 10.1002/hbm.25391. Epub 2021 Feb 27.