NCT01587326

Brief Summary

The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

April 26, 2012

Last Update Submit

May 13, 2012

Conditions

Depression

Keywords

cytokine, depression, escitalopram

Outcome Measures

Primary Outcomes (1)

  • The changes in cytokines

    Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α

    Week 0, Week 4

Secondary Outcomes (1)

  • The changes in Hamilton Depression Rating Scale

    week 0, week 4

Study Arms (1)

Escitalopram

EXPERIMENTAL

Escitalopram 10 mg/d to 20 mg/d

Drug: Escitalopram

Interventions

EscitalopramDRUG

escitalopram 10 mg/d to 20 mg/d

Also known as: Lexapro
Escitalopram

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV-defined Major depressive disorder, single episode
  • Age 20-65
  • Drug-naive
  • Hamilton Depression Rating Scale exceeding 14 scores

You may not qualify if:

  • Major medical disorders
  • Substance use
  • Pregnant
  • Allergy to escitalopram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beitou Armed Forces Hospital

Taipei, Taiwan

RECRUITING

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

  • Peishen Ho, M.D.

    Beitou Armed Forces Hospital

    STUDY CHAIR

Central Study Contacts

Pei-Shen Ho, M.D.

CONTACT

+886-2-28959808luke_and_tina@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

TW(1)