Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury

• Status: Unknown status
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Walter Reed Army Medical Center
• Collaborators: 59th Medical Wing; Hunter Holmes McGuire VA Medical Center; James A. Haley Veterans Administration Hospital; The Defense and Veterans Brain Injury Center; United States Naval Medical Center, San Diego; VA Palo Alto Health Care System; Wilford Hall Medical Center
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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