A Neuroimaging and Epigenetic Investigation of Antidepres... | NCT00703742

Studies
A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

NCT00703742

Sponsor

Kunming Medical University

Status

Completed

Last Update Posted

Sep 17, 2019Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Depression
Depression Secondary to Other Disease

Interventions

Escitalopram

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 20, 2008

First Submission Date that Met QC Criteria

Jun 20, 2008

First Posted Date

Jun 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2019

Last Update Posted Date

Sep 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuqi Cheng, Vise director, psychiatry department, Kunming Medical University, Kunming Medical UniversityPrincipal Investigator

Lead Sponsor

Kunming Medical UniversityOTHER

Collaborators

Name	Class
Chinese Academy of Sciences	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A,1	Experimental	A: Escitalopram, 20 mg/day,8weeks	Drug: Escitalopram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	A,1: Escitalopram, oral, 20 mg/day, 8 weeks	A,1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of fMRI after medication		baseline, 4 weeks, 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xu Xiufeng	Kunming Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Kunming Medical College		Kunming	Yunnan	650031	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42349919	Derived	Yang Y, Tao L, Zhao R, Bai R, Liu S, Zhang G, Li S, Xu X, Cheng Y, Xu J. Influence of sex and systemic lupus erythematosus disease status on cerebral cortex structure. Lupus Sci Med. 2026 Jun 25;13(1):e002032. doi: 10.1136/lupus-2026-002032.
37270840	Derived	Chu Z, Yuan L, He M, Cheng Y, Lu Y, Xu X, Shen Z. Atrophy of bilateral nucleus accumbens in melancholic depression. Neuroreport. 2023 Jun 7;34(10):493-500. doi: 10.1097/WNR.0000000000001915. Epub 2023 May 31.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572