Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:10/28/2018
Start Date:April 2014
End Date:November 2014

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP-7000 as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)

The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with
placebo in the treatment of patients with schizophrenia.

This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses
of RBP-7000 compared with placebo over an 8-week treatment period.


Inclusion Criteria:

- Males and females between the ages of 18 to 55 years, inclusive

- Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4,
text revision (DSM-IV-TR) criteria

- Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and
Rule (SAFER) interview

- Subjects who are otherwise healthy on the basis of their physical examination

Exclusion Criteria:

- Subjects who have an improvement in their total Positive and Negative Syndrome Scale
(PANSS) score of 20% or greater between the initial screening visit and the first day
of treatment.

- Subjects taking daily oral risperidone at a dose ≥ 6 mg/day

- Subjects who have received a depot antipsychotic within 120 days of screen

- Subjects with treatment resistant schizophrenia, as judged by the investigator, who
have been treated with antipsychotics for adequate durations and with adequate
dosages.
We found this trial at
32
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Long Beach, California 90806
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
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Austin, Texas 78754
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Austin, Texas 78756
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Cedarhurst, New York 11516
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Cerritos, CA
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Charlotte, North Carolina 28204
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Chicago, Illinois 60640
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Chicago, IL
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Dallas, Texas 75231
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Dallas, Texas 75243
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Dayton, OH
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Escondido, California 92025
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Fort Lauderdale, Florida 33308
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Glendale, California 91204
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Hoffman Estates, Illinois 60169
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Lake Charles, Louisiana 70601
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Las Vegas, Nevada 89102
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Little Rock, Arkansas 72211
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Long Beach, California 90813
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Marlton, New Jersey 08053
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North Miami, Florida 33021
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Oakland, California 94612
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32810
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Philadelphia, Pennsylvania 19139
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Pico Rivera, California 90660
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Saint Louis, Missouri 63141
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
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San Diego, California 92102
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Shreveport, Louisiana 71104
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Springdale, Arkansas 72764
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