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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 History of Changes |
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 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 |
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 |