Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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

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Affective Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Escitalopram-for MDD

Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.

Escitalopram Pill

Intervention Type DRUG

escitalopram 10\~20mg/day

Duloxetine-for MDD

Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.

Duloxetine

Intervention Type DRUG

duloxetine 30\~120mg/day

Mirtazepine-for MDD

Eligible patients were assigned to mirtazepine treatment based on investigators' clinical practice.

Mirtazapine Pill

Intervention Type DRUG

Mirtazapine 15\~45mg/day

other antidepressant-for MDD

Eligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice.

Other Antidepressants

Intervention Type DRUG

Interventions

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Escitalopram Pill

escitalopram 10\~20mg/day

Intervention Type DRUG

Duloxetine

duloxetine 30\~120mg/day

Intervention Type DRUG

Mirtazapine Pill

Mirtazapine 15\~45mg/day

Intervention Type DRUG

Other Antidepressants

Intervention Type DRUG

Other Intervention Names

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Lexapro Cymbalta Remeron

Eligibility Criteria

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Inclusion Criteria

1\. Patients with depression

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes