Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury
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ClinicalTrials.gov Identifier: NCT00208572
Verified October 2007 by Walter Reed Army Medical Center. Recruitment status was: Recruiting
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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)
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