RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)

Reviva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Schizophrenia; Schizoaffective Disorder

Treatments: Drug: placebo; Drug: RP5063; Drug: aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490086

RVP-20-001

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.

Enrollment: 234 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients providing informed consent prior to any study specific procedures
• Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), or schizoaffective disorder
• Patients with normal physical examination, laboratory, vital signs,and electrocardiogram (ECG)

Exclusion criteria

• Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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234 participants in 5 patient groups, including a placebo group

15 mg RP5063 daily

Experimental group

Description:

RP5063 15 mg once daily

Treatment:

Drug: RP5063

30 mg RP5063 daily

Experimental group

Description:

RP5063 30 mg once daily

Treatment:

Drug: RP5063

50 mg RP5063 daily

Experimental group

Description:

RP5063 50 mg once daily

Treatment:

Drug: RP5063

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: placebo

aripiprazole

Active Comparator group

Description:

aripiprazole 15 mg daily

Treatment:

Drug: aripiprazole