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
Recruitment status was Recruiting
Sponsor:
Walter Reed Army Medical Center
Collaborators:
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
First received: September 13, 2005
Last updated: October 4, 2007
Last verified: October 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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
| 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 Mental Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries 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 May 23, 2013