A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

This study has been completed.

Study NCT00044044 Information provided by Sunovion

First Received on August 16, 2002. Last Updated on September 6, 2011 History of Changes

Results First Received: February 1, 2011

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 20 mg Drug: Lurasidone 40mg Drug: Lurasidone 80 mg Drug: Haloperidol 10mg Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
20 mg	Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
40 mg	Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
80 mg	Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
10 mg Haloperidol	10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
Placebo	Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.

Participant Flow: Overall Study

	20 mg	40 mg	80 mg	10 mg Haloperidol	Placebo
STARTED	71	69	71	73	72
COMPLETED	27	28	31	29	36
NOT COMPLETED	44	41	40	44	36

Baseline Characteristics

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Reporting Groups

	Description
20 mg	Lurasidone 20 mg oral tablet taken once a day
40 mg	Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
80 mg	Lurasidone 80 mg oral tablet taken once a day
10 mg Haloperidol	10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
Placebo	Oral Capsule matching treatment group taken oce a day

Baseline Measures

	20 mg	40 mg	80 mg	10 mg Haloperidol	Placebo	Total
Number of Participants [units: participants]	71	67	71	72	72	353
Age [units: years] Mean ± Standard Deviation	40.7 ± 10.5	42.0 ± 10.9	42.2 ± 8.3	40.0 ± 10.5	41.0 ± 9.7	41.2 ± 10.0
Gender [units: participants]
Female	20	21	19	14	17	91
Male	51	46	52	58	55	262

Outcome Measures

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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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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 and Caveats

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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Results Point of Contact:

Name/Title: Josephine Cucchiaro, Executive Director
Organization: Sunovion
phone: 201-592-2050
e-mail: josephine.cucchiaro@sunovion.com

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00044044 History of Changes
Other Study ID Numbers:	D1050049
Study First Received:	August 16, 2002
Results First Received:	February 1, 2011
Last Updated:	September 6, 2011
Health Authority:	United States: Food and Drug Administration