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
Oceanside, California 92056
1031
mi
from 98109
Oceanside, CA
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
1434
mi
from 98109
Wichita, KS
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Austin, Texas 78754
1770
mi
from 98109
Austin, TX
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Austin, Texas 78756
1768
mi
from 98109
Austin, TX
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Cedarhurst, New York 11516
2417
mi
from 98109
Cedarhurst, NY
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977
mi
from 98109
Cerritos, CA
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Charlotte, North Carolina 28204
2282
mi
from 98109
Charlotte, NC
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Chicago, Illinois 60640
1733
mi
from 98109
Chicago, IL
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Dallas, Texas 75231
1678
mi
from 98109
Dallas, TX
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Dallas, Texas 75243
1676
mi
from 98109
Dallas, TX
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1959
mi
from 98109
Dayton, OH
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Escondido, California 92025
1040
mi
from 98109
Escondido, CA
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Fort Lauderdale, Florida 33308
2717
mi
from 98109
Fort Lauderdale, FL
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Glendale, California 91204
956
mi
from 98109
Glendale, CA
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Hoffman Estates, Illinois 60169
1704
mi
from 98109
Hoffman Estates, IL
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Lake Charles, Louisiana 70601
1954
mi
from 98109
Lake Charles, LA
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Las Vegas, Nevada 89102
874
mi
from 98109
Las Vegas, NV
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Little Rock, Arkansas 72211
1782
mi
from 98109
Little Rock, AR
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Long Beach, California 90813
982
mi
from 98109
Long Beach, CA
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Long Beach, California 90806
982
mi
from 98109
Long Beach, CA
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Marlton, New Jersey 08053
2385
mi
from 98109
Marlton, NJ
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North Miami, Florida 33021
2720
mi
from 98109
North Miami, FL
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Oakland, California 94612
678
mi
from 98109
Oakland, CA
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Oklahoma City, Oklahoma 73112
?
mi
from 98109
Oklahoma City, OK
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Orlando, Florida 32810
2541
mi
from 98109
Orlando, FL
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Philadelphia, Pennsylvania 19139
2373
mi
from 98109
Philadelphia, PA
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Pico Rivera, California 90660
968
mi
from 98109
Pico Rivera, CA
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Saint Louis, Missouri 63141
1706
mi
from 98109
Saint Louis, MO
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
1717
mi
from 98109
Saint Louis, MO
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San Diego, California 92102
1066
mi
from 98109
San Diego, CA
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Shreveport, Louisiana 71104
1822
mi
from 98109
Shreveport, LA
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Springdale, Arkansas 72764
1639
mi
from 98109
Springdale, AR
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