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| Sponsors and Collaborators: |
George Washington University Pfizer |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00786318 |
Purpose
The primary objective is to determine if ziprasidone is superior to standard therapies in the emergency department treatment of the acutely agitated patient. The primary outcome will be the length of time taken until the patient is ready to be evaluated by the psychiatric service, or until a disposition is made.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychosis Agitation Delirium |
Drug: ziprasidone Drug: Standard therapy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prospective Double Blind Randomized Trial of Intramuscular Ziprasidone Compared With Standard Antipsychotic Therapy For The Treatment Of The Acutely Agitated Patient In The Emergency Department |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jeremy Brown, MD | 202 741 2902 | |
| Contact: Dianne Lee, RN | 2027412917 |
| United States, District of Columbia | |
| The George Washington University Medical Center, Dept of Emergency Medicine | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Principal Investigator: Jeremy Brown, MD | |
More Information
| Responsible Party: | Dept of Emergency Medicine, The George Washington University Medical Center ( Jeremy Brown ) |
| Study ID Numbers: | 010411 |
| Study First Received: | November 5, 2008 |
| Last Updated: | November 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00786318 History of Changes |
| Health Authority: | United States: Federal Government |
|
Psychosis Agitation Delirium |
|
Neurotransmitter Agents Psychotropic Drugs Psychomotor Agitation Schizophrenia Haloperidol Signs and Symptoms Lorazepam Dopamine Mental Disorders Psychotic Disorders Dementia Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Delirium |
Tranquilizing Agents Central Nervous System Depressants Confusion Antipsychotic Agents Dyskinesias Cognition Disorders Serotonin Haloperidol decanoate Delirium, Dementia, Amnestic, Cognitive Disorders Neurologic Manifestations Emergencies Dopamine Agents Ziprasidone |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Psychomotor Agitation Signs and Symptoms Serotonin Antagonists Mental Disorders Therapeutic Uses Psychomotor Disorders Psychotic Disorders Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Delirium |
Tranquilizing Agents Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Confusion Antipsychotic Agents Dyskinesias Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Serotonin Agents Neurologic Manifestations Dopamine Agents Ziprasidone Central Nervous System Agents |
