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Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00208572
Recruitment Status : Unknown
Verified October 2007 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
First Posted : September 21, 2005
Last Update Posted : October 5, 2007
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Drug: Citalopram

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Citalopram for Anxiety Disorders Following Traumatic Brain Injury
Study Start Date : November 2003
Estimated Study Completion Date : February 2008

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. DSM-IV diagnostic criteria for Anxiety Disorder Due to General Medical Condition
  2. Spielberger State Anxiety Inventory

Secondary Outcome Measures :
  1. Other psychiatric and psychosocial scales
  2. Neuropsychological test scores
  3. Work Status and Military Duty Status

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208572

Contact: Michael Jaffee, MD 202-782-6345 michael.jaffee@amedd.army.mil
Contact: Jamie A Fraser, MPH 202-782-3057 jamie.fraser@amedd.army.mil

United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20012
Contact: Jamie A Fraser, MPH    202-782-3057    jamie.fraser@amedd.army.mil   
Contact: Karen Schwab, PhD    202-782-3132    karen.schwab@amedd.army.mil   
Sponsors and Collaborators
Walter Reed Army Medical Center
The Defense and Veterans Brain Injury Center
VA Palo Alto Health Care System
Hunter Holmes McGuire VA Medical Center
United States Naval Medical Center, San Diego
Wilford Hall Medical Center
James A. Haley Veterans Administration Hospital
Principal Investigator: Michael Jaffee, MD The Defense and Veterans Brain Injury Center
More Information

ClinicalTrials.gov Identifier: NCT00208572     History of Changes
Other Study ID Numbers: 03-71013
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 5, 2007
Last Verified: October 2007

Keywords provided by Walter Reed Army Medical Center:
Traumatic Brain Injury; Anxiety Disorders; SRI Treatment

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Anxiety Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents