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A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

Primary Purpose

Depression, Depression Secondary to Other Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Escitalopram

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

DSM-IV Major Depression or Dysthymia
Age 18-65
Physically healthy
Drug-free

Exclusion Criteria:

Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
History of Psychosis or Epilepsy
Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
Bipolar I
Need for wash-out from effective treatment in order to participate
Pregnant
High suicide risk
Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants

Sites / Locations

The First Affiliated Hospital of Kunming Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A,1

Arm Description

A: Escitalopram, 20 mg/day,8weeks

Outcomes

Primary Outcome Measures

change of fMRI after medication

Secondary Outcome Measures

Full Information

NCT ID

NCT00703742

First Posted

June 20, 2008

Last Updated

September 14, 2019

Sponsor

Kunming Medical University

Collaborators

Chinese Academy of Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00703742

Brief Title

A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

Official Title

A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kunming Medical University

Collaborators

Chinese Academy of Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is: to find out the structural or functional effects of selective serotonin reuptake inhibitors (SSRI) in major depressive disorder (MDD); find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (SLE). find the relationship between the efficacy of antidepressant and the change of neuroimaging in MDD to find possible predispose to MDD to explore the DNA methylation status in depression;

Detailed Description

to explore the pathology of depression to identify the difference between MDD and depression secondary to other disease ,especially autoimmune disease to explore the effect of gene-environment interaction on the epigenetic regulation of the depression

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Depression Secondary to Other Disease

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A,1

Arm Type

Experimental

Arm Description

A: Escitalopram, 20 mg/day,8weeks

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

A,1: Escitalopram, oral, 20 mg/day, 8 weeks

Primary Outcome Measure Information:

Title

change of fMRI after medication

Time Frame

baseline, 4 weeks, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: DSM-IV Major Depression or Dysthymia Age 18-65 Physically healthy Drug-free Exclusion Criteria: Body metal (e.g., wire stitches, screws in bones, stainless steel hips) History of Psychosis or Epilepsy Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Bipolar I Need for wash-out from effective treatment in order to participate Pregnant High suicide risk Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xu Xiufeng

Organizational Affiliation

Kunming Medical University

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital of Kunming Medical College

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650031

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25393297

Citation

Cheng Y, Xu J, Yu H, Nie B, Li N, Luo C, Li H, Liu F, Bai Y, Shan B, Xu L, Xu X. Delineation of early and later adult onset depression by diffusion tensor imaging. PLoS One. 2014 Nov 13;9(11):e112307. doi: 10.1371/journal.pone.0112307. eCollection 2014.

Results Reference

derived

PubMed Identifier

20231206

Citation

Xu J, Cheng Y, Chai P, Lu Z, Li H, Luo C, Li X, Li L, Zhou Q, Chen B, Cao J, Xu X, Shan B, Xu L, Wen J. White-matter volume reduction and the protective effect of immunosuppressive therapy in systemic lupus erythematosus patients with normal appearance by conventional magnetic resonance imaging. J Rheumatol. 2010 May;37(5):974-86. doi: 10.3899/jrheum.090967. Epub 2010 Mar 15.

Results Reference

derived

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A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

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