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Treatment of Citalopram for Anxiety Disorders Following a Traumatic Brain Injury
This study is currently recruiting participants.
Verified by Walter Reed Army Medical Center, October 2007
First Received: September 13, 2005   Last Updated: October 4, 2007   History of Changes
Sponsors and Collaborators: Walter Reed Army Medical Center
The Defense and Veterans Brain Injury Center
VA Palo Alto Health Care System
Hunter McGuire VA Medical System, Richmond
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
  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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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
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 McGuire VA Medical System, Richmond
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

Study ID Numbers: 03-71013, WU#03-71013
Study First Received: September 13, 2005
Last Updated: October 4, 2007
ClinicalTrials.gov Identifier: NCT00208572     History of Changes
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

Study placed in the following topic categories:
Craniocerebral Trauma
Neurotransmitter Agents
Cholinergic Antagonists
Psychotropic Drugs
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Cholinergic Agents
Brain Diseases
Serotonin Uptake Inhibitors
Citalopram
Serotonin
Muscarinic Antagonists
Anxiety Disorders
Mental Disorders
Peripheral Nervous System Agents
Brain Injuries
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

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

ClinicalTrials.gov processed this record on August 30, 2009