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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 |
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Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00208572 |
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 |
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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 |
Estimated Enrollment: | 104 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | February 2008 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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)
Exclusion Criteria:
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 |
Principal Investigator: | Michael Jaffee, MD | The Defense and Veterans Brain Injury Center |
Study ID Numbers: | 03-71013, WU#03-71013 |
Study First Received: | September 13, 2005 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00208572 |
Health Authority: | United States: U.S. Army Medical Research and Materiel Command (USAMRMC); United States: Federal Government |
Traumatic Brain Injury; Anxiety Disorders; SRI Treatment |
Craniocerebral Trauma Anxiety Disorders Mental Disorders Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Dexetimide Brain Diseases Brain Injuries Citalopram Serotonin |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |