RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)

Phase 2

Completed

• Conditions: Health Condition 1: null- Acute Schizophrenia Schizoaffective Disorder

• Registration Number: CTRI/2012/08/002944
• Lead Sponsor: Reviva Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 228

Inclusion Criteria

•Subjects with a clinical diagnosis of acute exacerbation of schizophrenia or schizoaffective disorder (at least one year prior to screening) according to DSM-IV-TR criteria as aided by Mini International Neuropsychiatric Interview (M.I.N.I.) 6.0 for Schizophrenia and Psychotic Disorders Studies (Appendix VI).

•Subjects experiencing an acute exacerbation of psychosis where the following criteria are met:

oScreening score on the BPRS of >36 and BPRS psychosis cluster a minimum score of 4 or higher on at least two of the four items: suspiciousness, conceptual disorganization, hallucinatory behavior, and/or unusual thought content

oCurrent exacerbating episode has lasted no longer than 4 weeks

Exclusion Criteria

•Female subjects who are pregnant or lactating

•Subjects presenting concurrent dementia, delirium, mental retardation, epilepsy/seizure,drug-induced psychosis, mood disorders, including bipolar mania and major depression

•Presence or history within the previous 3 months of significant and/or uncontrolled hematological, renal, hepatic, endocrinological, neurological or cardiovascular disease

•Clinically significant abnormalities as per Investigatorâ??s discretion

•History of neuroleptic malignant syndrome induced by any antipsychotic medication in the past

•Subjects with a history of Human Immunodeficiency Virus (HIV) infection but no HIV or Hepatitis testing will be done

•Subjects who meet DSM-IV criteria for alcohol or any substance dependence disorder within 3 months prior to screening

•A positive qualitative urine drug test by dipstick method at screening or evidence of either any withdrawal from or acute intoxication such as alcohol, cocaine, opiates, (meth) amphetamines, marijuana and barbiturates

•Subjects with history of electroconvulsive therapy (ECT) within the past 3 months of screening or who may require ECT during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified