Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00208572
First received: September 13, 2005
Last updated: October 4, 2007
Last verified: October 2007
  Purpose

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 Intervention
Traumatic Brain Injury
Drug: Citalopram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Citalopram for Anxiety Disorders Following Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

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

Secondary Outcome Measures:
  • Other psychiatric and psychosocial scales
  • Neuropsychological test scores
  • Work Status and Military Duty Status

Estimated Enrollment: 104
Study Start Date: November 2003
Estimated Study Completion Date: February 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208572

Contacts
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

Locations
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
Investigators
Principal Investigator: Michael Jaffee, MD The Defense and Veterans Brain Injury Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208572     History of Changes
Other Study ID Numbers: 03-71013, WU#03-71013
Study First Received: September 13, 2005
Last Updated: October 4, 2007
Health Authority: United States: U.S. Army Medical Research and Materiel Command (USAMRMC)
United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 23, 2014