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

Indivior

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: RBP-7000; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02109562

RB-US-09-0010

Details and patient eligibility

About

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.

Enrollment: 354 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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354 participants in 3 patient groups, including a placebo group

RBP-7000 90 mg

Experimental group

Description:

Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections.

Treatment:

Drug: RBP-7000

Drug: Risperidone

RBP-7000 120 mg

Experimental group

Description:

Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.

Treatment:

Drug: RBP-7000

Drug: Risperidone

Placebo

Placebo Comparator group

Description:

Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.

Treatment:

Drug: Placebo

Drug: Risperidone