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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Stanley Medical Research Institute ACADIA Pharmaceuticals Inc. |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00628420 |
To determine the safety and tolerability of ACP-104 after oral administration of single doses in comparison with placebo to schizophrenia or other psychotic disorders.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: ACP-104 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled, Single Oral Dose Study to Demonstrate the Safety, Tolerability, and Pharmacokinetics of ACP-104 (N-Desmethylclozapine) in Schizophrenia, or Other Psychotic Disorders. |
Enrollment: | 45 |
Study Start Date: | January 2005 |
Study Completion Date: | October 2007 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Patients recieved single low dose of ACP-104
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Drug: ACP-104
25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks
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2
Patients recieved a high dose of ACP-104
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Drug: ACP-104
Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks
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3
Patients recieved a placebo
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Drug: Placebo
patients will be given a placebo: 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg, 200mg, 225mg, 250mg, 275mg, or 300mg (to match the doses given) daily for 2 weeks.
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Thirty-six healthy patients with schizophrenia or psychotic disorders, each of whom will be drug-free at study initiation, will be admitted to the hospital and will each receive two doses of ACP-104, and one dose of placebo, orally every 3-5 days over a two-week period. The patients will be divided into six groups of up to six and minimum of 3 patients each. Group 1 will consist of six patients who will receive single 25mg and 50mg doses of ACP-104 and placebo in random, but rising dose, order over a two-week period. Data from group one will be collected to determine ACP-104's safety, tolerability, and pharmacokinetics. Group 2 will be enrolled in the study once study data from Group 1 has demonstrated the safety of ACP-104. Group 2 will receive a 25mg pre-conditioning dose of ACP-104. Following the pre-conditioning dose, 75mg and 100mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period. Group 3 will be enrolled in the study once study data from Group 2 has demonstrated the safety of ACP-104. Group 3 will receive a 25mg pre-conditioning dose of ACP-104. Following the pre-conditioning dose, 125mg and 150mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period. Group 4 will be enrolled in the study once study data from Group 3 has demonstrated the safety of ACP-104. Group 4 will receive a 25mg pre-conditioning dose of ACP-104. Following the pre-conditioning dose, 175mg and 200mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period. Group 5 will be enrolled in the study once study data from Group 4 has demonstrated the safety of ACP-104. Group 5 will receive a 25mg pre-conditioning dose of ACP-104. Following the pre-conditioning dose, 225mg and 250mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two week period. Group 6 will be enrolled in the study once study data from Group 5 has demonstrated the safety of ACP-104. Group 6 will receive a 25mg pre-conditioning dose of ACP-104. Following the pre-conditioning dose, 275mg and 300mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period. Groups 1-6 will be monitored closely and safety procedures and evaluations will be performed on all medication days. Safety assessments will include: physical examinations, vital signs (3-positional blood pressure and pulse rate, respiration rate, and oral body temperature), clinical laboratory tests, ECGs (Electrocardiogram), coordination tests, questions about symptoms and side effects. Once all medication days have been completed, the condition of the patient will be assessed, and, at that time, it will be determined whether the patient's condition is suitable for release from the hospital or whether further monitoring of the patient's condition as an inpatient is needed.
Ages Eligible for Study: | 20 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any patient judged by the principal investigator to be inappropriate for the study.
United States, Texas | |
The University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
Veteran's Affairs Medical Center | |
Dallas, Texas, United States, 75216 |
Responsible Party: | UT Southwestern Medical Center ( Carol A. Tamminga, MD, Professor ) |
Study ID Numbers: | 082004-051 |
Study First Received: | February 24, 2008 |
Last Updated: | February 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00628420 |
Health Authority: | United States: Food and Drug Administration |
Schizophrenia N-desmethylclozapine clozapine |
psychosis randomized placebo studies |
Schizophrenia Mental Disorders Clozapine Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |