Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury

Status unconfirmed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00208572

Run by

Walter Reed Army Medical Center

People needed

104

Starts

2003-11-01

Expected to finish

2008-02-01

Last updated by the study team

2007-10-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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…

• 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

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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