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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Schizophrenia |
| Interventions: |
Drug: Lurasidone Drug: Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Description | |
|---|---|
| Lurasidone 80 mg | 2 40 mg lurasidone tablets taken once/day |
| Placebo | Matching placebo to lurasidone 40 mg tablets taken once/day |
| Lurasidone 80 mg | Placebo | |
|---|---|---|
| STARTED | 90 | 90 |
| COMPLETED | 52 | 47 |
| NOT COMPLETED | 38 | 43 |
Baseline Characteristics
| Description | |
|---|---|
| Lurasidone 80 mg | 2 40 mg lurasidone tablets taken once/day |
| Placebo | Matching placebo to lurasidone 40 mg tablets taken once/day |
| Lurasidone 80 mg | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
90 | 90 | 180 |
|
Age
[units: years] Mean ± Standard Deviation |
39.7 ± 9.91 | 41.9 ± 9.78 | 40.8 ± 9.88 |
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Gender
[units: participants] |
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| Female | 22 | 20 | 42 |
| Male | 68 | 70 | 138 |
Outcome Measures
| 1. Primary: | Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score [ Time Frame: Baseline and 6 weeks ] |
| 2. Secondary: | Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores [ Time Frame: Baseline and 6 weeks ] |
| 3. Secondary: | Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores [ Time Frame: Baseline and 6 weeks ] |
| 4. Secondary: | Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores [ Time Frame: Baseline and 6 weeks ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00088634 History of Changes |
| Other Study ID Numbers: | D1050196 |
| Study First Received: | July 30, 2004 |
| Results First Received: | February 1, 2011 |
| Last Updated: | September 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |