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 |
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.
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
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