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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: Completed Phase 3 study, sponsored by University of Maryland, Baltimore.
NCT00161018 is a Phase 3 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00161018 record still lists
NCT00161018 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Quetiapine, Risperidone, Fluphenazine is the first listed.
NCT00161018 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00161018's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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