Status:
UNKNOWN
Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury
Lead Sponsor:
Walter Reed Army Medical Center
Collaborating Sponsors:
The Defense and Veterans Brain Injury Center
VA Palo Alto Health Care System
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Detailed Description
Anxiety occurs commonly after traumatic brain injury and may influence cognitive, behavioral, and somatic presentations that may interfere with patients' recovery and adaptation to life after brain in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Severe prior neurologic or psychiatric illness (based on DSM-IV criteria), such as stroke or psychosis. (Previous non-psychotic depression/anxiety is not an exclusion criterion)
- 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®
- Previous severe traumatic brain injury (defined as TBI with period of unconsciousness greater than 1 week. This exclusion refers only to TBIs prior to the current injury.
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00208572
Start Date
November 1 2003
End Date
February 1 2008
Last Update
October 5 2007
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20012