New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00161018|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 19, 2019
The purpose of this study is to:
- Evaluate the efficacy and safety of the new antipsychotics, quetiapine (300-500mg/day) and risperidone (3-4mg/day) compared to each other and to fluphenazine (10-15mg/day), a high potency typical antipsychotic in patients who meet the DSM IV criteria for schizophrenia.
- To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not responded to conventional and newer antipsychotics.
- To evaluate the effectiveness of quetiapine (300-500mg/day), and risperidone (3-5mg/day) compared to each other and fluphenazine (10-15mg/day) in the treatment of hostility and aggression in treatment-resistant schizophrenic patients.
- To evaluate the effectiveness of quetiapine (300-500mg/day) and risperidone (3-5mg/day) compared to each other and fluphenazine (10-15mg/day) on rates of discharge, quality of life, and independent living skills.
- To assess prolactin levels and to evaluate any relationship with sexual dysfunction and menstrual irregularities.
- To evaluate the possible differential impact of treatment conditions on cognitive functioning including measures of attention, motor speed, problem solving, verbal and visual memory, and verbal processing speed.
- To measure changes in weight and health consequences associated with weight changes.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Quetiapine, Risperidone, Fluphenazine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Actual Study Start Date :||November 2003|
|Actual Primary Completion Date :||November 2004|
|Actual Study Completion Date :||November 2004|
- To evaluate the efficacy and safety of the new antipsychotics, quetiapine(300-500mg/day) and risperidone(3-5mg/day) compared to each other and to fluphenazine(10-15mg/day), a high potency typical antipsychotic
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161018
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator:||Robert R Conley, MD||MPRC|