Recruiting

Citalopram

Sponsor:

Walter Reed Army Medical Center

Code:

NCT00208572

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Citalopram

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT00208572

Start date

Nov, 2003

Status verified date

Oct, 2007

Completion date

Feb, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Citalopram

Primary outcome measure

  • DSM-IV diagnostic criteria for Anxiety Disorder Due to General Medical Condition [ Time Frame: undefined ]
  • Spielberger State Anxiety Inventory [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Michael Jaffee, MD

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

Jamie A Fraser, MPH

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

Locations

Walter Reed Army Medical Center

Recruiting

Washington, District of Columbia, United States, 20012

Contacts

Jamie A Fraser, MPH

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

Karen Schwab, PhD

202-782-3132karen.schwab@amedd.army.mil

More Information

Sponsor

Walter Reed Army Medical Center

Last update posted

Oct 5, 2007

Last verified

Oct, 2007

Keywords

  • Traumatic Brain Injury; Anxiety Disorders; SRI Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed Army Medical Center on 2007-10-05.