Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

NCT03294525 | Unknown

• 1 other identifier: 001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Affective Disorder

Outcome Measures

Primary Outcomes (2)

• reduction in HAMD total scores

  reduction more than 50% was regarded as response

  8 weeks

• remision

  HAMD total score less than 7

  8 weeks

Study Arms (4)

Escitalopram-for MDD

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

Drug: Escitalopram Pill

Duloxetine-for MDD

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

Drug: Duloxetine

Mirtazepine-for MDD

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

Drug: Mirtazapine Pill

other antidepressant-for MDD

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

Drug: Other Antidepressants

Interventions

Escitalopram Pill DRUG

escitalopram 10\~20mg/day

Also known as: Lexapro

Escitalopram-for MDD

Duloxetine DRUG

duloxetine 30\~120mg/day

Also known as: Cymbalta

Duloxetine-for MDD

Mirtazapine Pill DRUG

Mirtazapine 15\~45mg/day

Also known as: Remeron

Mirtazepine-for MDD

Other Antidepressants DRUG

other antidepressant-for MDD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with major depressive disorder

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Institute of mental health, Peking University

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (3)

• Dai YR, Wu YK, Chen X, Zeng YW, Li K, Li JT, Su YA, Zhu LL, Yan CG, Si TM. Eight-week antidepressant treatment changes intrinsic functional brain topology in first-episode drug-naive patients with major depressive disorder. J Affect Disord. 2023 May 15;329:225-234. doi: 10.1016/j.jad.2023.02.126. Epub 2023 Feb 28.

  PMID: 36858265 DERIVED

• 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.

  PMID: 35788366 DERIVED

• 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.

  PMID: 33638263 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were collected by venepuncture.

MeSH Terms

Conditions

Mood Disorders

Interventions

Escitalopram; Duloxetine Hydrochloride; Mirtazapine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Study Officials

• Tianmei Si, PhD

  Sixth hospital of beijing university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunai Su, PhD

CONTACT

010-62723761; suyunai@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychopharmacology Division

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: September 27, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: August 1, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)