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Atypical Antipsychotic
Risperdal for Schizophrenia
Phase 4
Waitlist Available
Led By Steven G Potkin, M.D.
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Summary
The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.
Eligible Conditions
- Schizophrenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: RisperdalExperimental Treatment1 Intervention
Risperdal 2-8mg per day
Group II: InvegaExperimental Treatment1 Intervention
Invega 6-12mg per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risperidone
FDA approved
Paliperidone
FDA approved
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
560 Previous Clinical Trials
1,930,006 Total Patients Enrolled
3 Trials studying Schizophrenia
174 Patients Enrolled for Schizophrenia
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
310,289 Total Patients Enrolled
26 Trials studying Schizophrenia
7,060 Patients Enrolled for Schizophrenia
Steven G Potkin, M.D.Principal InvestigatorUC Irvine
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