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NCT00161018 · ClinicalTrials.gov registry record · Phase 3
New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia
A Phase 3 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT00161018 is a Phase 3 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 150 participants.
The verdict
NCT00161018, a Phase 3 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
The purpose of this study is to: 1. 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. 2. To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not responded to conventional and newer antipsychotics. 3. 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. 4. 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. 5. To assess prolactin levels and to evaluate any relationship with sexual dysfunction and menstrual irregularities. 6. 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. 7. To measure changes in weight and health consequences associated with weight changes.
Interventions
- DRUG Quetiapine, Risperidone, Fluphenazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-11 |
| Est. Completion | 2004-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00161018
The ClinicalTrials.gov registry entry for NCT00161018 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Quetiapine, Risperidone, Fluphenazine is the first listed.
NCT00161018 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00161018 about?
NCT00161018 is a clinical study titled "New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia". The purpose of this study is to: 1. 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 schizoph...
What is the current status of trial NCT00161018?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2003-11. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00161018?
The interventions under investigation include: Quetiapine, Risperidone, Fluphenazine (DRUG).
Who is sponsoring clinical trial NCT00161018?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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