NCT00703742

Brief Summary

The purpose of this study is:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

June 20, 2008

Last Update Submit

September 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • change of fMRI after medication

    baseline, 4 weeks, 8 weeks

Study Arms (1)

A,1

EXPERIMENTAL

A: Escitalopram, 20 mg/day,8weeks

Drug: Escitalopram

Interventions

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

A,1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Kunming Medical College

Kunming, Yunnan, 650031, China

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Xu Xiufeng

    Kunming Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vise director, psychiatry department, Kunming Medical University

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations