RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

NCT ID: NCT01490086

Last Updated: 2025-08-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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15 mg RP5063 daily

RP5063 15 mg once daily

Group Type EXPERIMENTAL

RP5063

Intervention Type DRUG

daily

30 mg RP5063 daily

RP5063 30 mg once daily

Group Type EXPERIMENTAL

RP5063

Intervention Type DRUG

daily

50 mg RP5063 daily

RP5063 50 mg once daily

Group Type EXPERIMENTAL

RP5063

Intervention Type DRUG

daily

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

daily

aripiprazole

aripiprazole 15 mg daily

Group Type ACTIVE_COMPARATOR

aripiprazole

Intervention Type DRUG

daily

Interventions

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RP5063

daily

Intervention Type DRUG

placebo

daily

Intervention Type DRUG

aripiprazole

daily

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reviva Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M Cantillon

Role: STUDY_DIRECTOR

Fundacion REVIVA, Red de VIH del Valle del Cauca

Locations

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Reviva site

Philadelphia, Pennsylvania, United States

Site Status

Reviva site

Bangalore, , India

Site Status

Reviva site

Chennai, , India

Site Status

Reviva site

Guntur, , India

Site Status

Reviva site

Jaipur, , India

Site Status

Reviva site

Kanpur, , India

Site Status

Reviva site

Lucknow, , India

Site Status

Reviva site

Mangalore, , India

Site Status

Reviva site

Johor Bahru, , Malaysia

Site Status

Reviva site

Kuala Lumpur, , Malaysia

Site Status

Reviva Site

Tanjung Rambutan, , Malaysia

Site Status

Reviva site

Chisinau, , Moldova

Site Status

Reviva site

Mandaluyong, , Philippines

Site Status

Reviva site

Mandurriao, , Philippines

Site Status

Reviva site

Subandaku, , Philippines

Site Status

Countries

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United States India Malaysia Moldova Philippines

Other Identifiers

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RVP-20-001

Identifier Type: -

Identifier Source: org_study_id

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