NCT00208572

Brief Summary

The proposal will assess the effectiveness of SRI treatment of anxiety following TBI. We hypothesize that participants will report significantly fewer and less severe anxiety symptoms after a 12-week course of citalopram than after a 12-week course of placebo.

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
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

October 5, 2007

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

October 4, 2007

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Anxiety Disorders; SRI Treatment

Outcome Measures

Primary Outcomes (2)

  • DSM-IV diagnostic criteria for Anxiety Disorder Due to General Medical Condition

  • Spielberger State Anxiety Inventory

Secondary Outcomes (3)

  • Other psychiatric and psychosocial scales

  • Neuropsychological test scores

  • Work Status and Military Duty Status

Interventions

CitalopramDRUG

Eligibility Criteria

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

You may qualify if:

  • Traumatic brain injury patients between 3 and 24 months post injury.
  • Clear evidence/documentation of brain injury:
  • i. documented/witnessed loss of consciousness, post traumatic amnesia ii. alteration in mental status (dazed/confused), and/or physical evidence of iii. trauma (MRI/CT hemorrhage/contusion)
  • Traumatic brain injury with recovery to a Rancho los Amigos level 7 or 8 (alert and oriented).
  • Meet criteria for DSM IV diagnosis Anxiety Disorder Due to a General Medical Condition.
  • The symptoms of the anxiety disorder are not being controlled adequately with or without treatment at the time of referral.
  • Military or Veteran beneficiary
  • Men and non-pregnant/non-breastfeeding females
  • Aged 18-65

You may not qualify if:

  • Current/prior unstable medical condition that could affect current brain function (ex. clear anoxic episode, cardiac arrest, current uncontrolled diabetes)
  • Contraindication to the use of citalopram.
  • Concomitant use of monoamine oxidase inhibitors (MAOIs), cimetidine, lithium, theophylline, digoxin, sumatriptan, warfarin, carbamazepine, triazolam, ketoconazole, CYP3A4 and 2C19 inhibitors, and metoprolol.
  • Hypersensitivity to citalopram or any of the inactive ingredients in Celexa®
  • Pregnancy (blood test required for females)
  • Breastfeeding
  • Current active suicidal ideation
  • Inability to discontinue other psychotropic medications, such as tricyclic antidepressants or another SRI
  • Current drug/alcohol abuse or dependence
  • Previous unsuccessful trial of citalopram
  • Participation in a concurrent drug or treatment trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20012, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticAnxiety Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michael Jaffee, MD

    The Defense and Veterans Brain Injury Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Jaffee, MD

CONTACT

202-782-6345michael.jaffee@amedd.army.mil

Jamie A Fraser, MPH

CONTACT

202-782-3057jamie.fraser@amedd.army.mil

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2003

Study Completion

February 1, 2008

Last Updated

October 5, 2007

Record last verified: 2007-10

Locations

US(1)