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
sites
North Miami, Florida 33021
977
mi
from 43215
North Miami, FL
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
784
mi
from 43215
Wichita, KS
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Austin, Texas 78754
1057
mi
from 43215
Austin, TX
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Austin, Texas 78756
1063
mi
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Austin, TX
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Cedarhurst, New York 11516
491
mi
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Cedarhurst, NY
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1967
mi
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Cerritos, CA
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Charlotte, North Carolina 28204
349
mi
from 43215
Charlotte, NC
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Chicago, Illinois 60640
274
mi
from 43215
Chicago, IL
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Dallas, Texas 75243
903
mi
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Dallas, TX
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65
mi
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Dayton, OH
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Escondido, California 92025
1935
mi
from 43215
Escondido, CA
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Fort Lauderdale, Florida 33308
970
mi
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Fort Lauderdale, FL
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Glendale, California 91204
1970
mi
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Glendale, CA
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Hoffman Estates, Illinois 60169
302
mi
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Hoffman Estates, IL
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Lake Charles, Louisiana 70601
884
mi
from 43215
Lake Charles, LA
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Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
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Little Rock, Arkansas 72211
622
mi
from 43215
Little Rock, AR
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Long Beach, California 90813
1977
mi
from 43215
Long Beach, CA
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Long Beach, California 90806
1976
mi
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Long Beach, CA
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Marlton, New Jersey 08053
428
mi
from 43215
Marlton, NJ
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Oakland, California 94612
2098
mi
from 43215
Oakland, CA
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Oceanside, California 92056
1944
mi
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Oceanside, CA
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Oklahoma City, Oklahoma 73112
?
mi
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Oklahoma City, OK
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Orlando, Florida 32810
788
mi
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Orlando, FL
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Philadelphia, Pennsylvania 19139
416
mi
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Philadelphia, PA
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Pico Rivera, California 90660
1965
mi
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Pico Rivera, CA
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Saint Louis, Missouri 63141
408
mi
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Saint Louis, MO
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
406
mi
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Saint Louis, MO
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San Diego, California 92102
1949
mi
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San Diego, CA
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Shreveport, Louisiana 71104
788
mi
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Shreveport, LA
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Springdale, Arkansas 72764
657
mi
from 43215
Springdale, AR
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