NCT00162916

Brief Summary

The purpose of the study is to explore to what extent continuing the antidepressant medication citalopram (Celexa), after depression has responded to treatment, helps prevent the return of depressive symptoms in patients with recent traumatic brain injury (TBI).

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
21

participants targeted

Target at below P25 for phase_4 depression

Timeline
Completed

Started May 2005

Typical duration for phase_4 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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

3 years

First QC Date

September 10, 2005

Last Update Submit

June 3, 2008

Conditions

Depression

Keywords

Traumatic Brain InjuryDepressionAntidepressant medicationDouble-Blind StudyBrain InjuriesAntidepressive AgentsCitalopramDouble-Blind Method

Outcome Measures

Primary Outcomes (1)

  • recurrence of major depression by administering the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions Scale (CGI) every 4 weeks for 40 weeks

    40 weeks

Secondary Outcomes (2)

  • general cognitive function at baseline, 10 weeks and on termination of the trial

    40 weeks

  • list of adverse drug events at baseline, 10 weeks and on termination of the trial

    40 weeks

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

2

EXPERIMENTAL
Drug: citalopram

Interventions

citalopramDRUG

20mg or 40mg, once daily, for 40 weeks

Also known as: Celexa
2
PlaceboDRUG

Cornstarch

1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • TBI within the last year (this is consistent with clinic population)
  • Mild TBI
  • Written, informed consent
  • Diagnosis of major depressive episode using the depression module of the Structured Clinical Interview for DSM-IV Axis I disorders (SCID-IV), and baseline 17-item Hamilton Depression (HAM-D) Rating Scale score of 16 and above (prior to selective serotonin reuptake inhibitor \[SSRI\] treatment)
  • Response to citalopram 20 or 40mg/d, as defined as a reduction in baseline HAM-D of \>= 50%, and HAM-D score of 10 or below; or response to citalopram defined as not meeting DSM-IV criteria for major depression and Clinical Global Impression - severity of mildly ill, borderline ill, or normal and a Clinical Global Impression - improvement of much improved or very much improved impression.

You may not qualify if:

  • Prior TBI or other focal brain disease (e.g., stroke, tumour)
  • Significant acute medical illness including: drug overdose; severely disturbed liver, kidney, lung or heart function; anemia; hypothyroidism; uncontrolled diabetes; Parkinson's disease; Huntington's chorea; progressive supranuclear palsy; brain tumor; subdural hematoma; or multiple sclerosis.
  • Current alcohol or substance abuse
  • A brain computed tomographic (CT) scan revealing focal lesions that could not be interpreted as consistent with TBI
  • Presence of premorbid psychiatric diagnosis of schizophrenia, dementia or bipolar disorder
  • Prior episode of major depression in two years prior to TBI, based on SCID-IV interview
  • Prior treatment with citalopram or contraindications to receiving treatment with citalopram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • Rapoport MJ, Mitchell RA, McCullagh S, Herrmann N, Chan F, Kiss A, Feinstein A, Lanctot KL. A randomized controlled trial of antidepressant continuation for major depression following traumatic brain injury. J Clin Psychiatry. 2010 Sep;71(9):1125-30. doi: 10.4088/JCP.09m05086blu. Epub 2010 Apr 20.

    PMID: 20441723DERIVED

Related Links

MeSH Terms

Conditions

DepressionBrain Injuries, TraumaticBrain Injuries

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mark J Rapoport, MD, FRCPC

    Sunnybrook Health Sciences Centre, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 13, 2005

Study Start

May 1, 2005

Primary Completion

May 1, 2008

Study Completion

October 1, 2008

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations

CA(1)