Phase 2
N=180
A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00088634 ↗Enrolled (actual)
180
Serious AEs
2.8%
Results posted
Mar 2011
Primary outcome: Primary: Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score — -8.9; -4.2 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lurasidone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Dec 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score |
-8.9; -4.2 | <0.05 sig |
| SECONDARY Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores |
-14.1; -5.5 | <0.05 sig |
| SECONDARY Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores |
-0.6; -0.2 | <0.05 sig |
| SECONDARY Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores |
-2.9; -0.1 | <0.05 sig |
Summary
A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia
Eligibility Criteria
Inclusion Criteria
- Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
- The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
- If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception
Exclusion Criteria
- The patient has used an investigational drug within the past 30 days
- The patient has participated in a previous study of this compound
Data sourced from ClinicalTrials.gov (NCT00088634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.