RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder
NCT ID: NCT01490086
Last Updated: 2025-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
234 participants
INTERVENTIONAL
2011-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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15 mg RP5063 daily
RP5063 15 mg once daily
RP5063
daily
30 mg RP5063 daily
RP5063 30 mg once daily
RP5063
daily
50 mg RP5063 daily
RP5063 50 mg once daily
RP5063
daily
Placebo
Placebo once daily
placebo
daily
aripiprazole
aripiprazole 15 mg daily
aripiprazole
daily
Interventions
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RP5063
daily
placebo
daily
aripiprazole
daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Reviva Pharmaceuticals
INDUSTRY
Responsible Party
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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
Reviva site
Bangalore, , India
Reviva site
Chennai, , India
Reviva site
Guntur, , India
Reviva site
Jaipur, , India
Reviva site
Kanpur, , India
Reviva site
Lucknow, , India
Reviva site
Mangalore, , India
Reviva site
Johor Bahru, , Malaysia
Reviva site
Kuala Lumpur, , Malaysia
Reviva Site
Tanjung Rambutan, , Malaysia
Reviva site
Chisinau, , Moldova
Reviva site
Mandaluyong, , Philippines
Reviva site
Mandurriao, , Philippines
Reviva site
Subandaku, , Philippines
Countries
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Other Identifiers
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RVP-20-001
Identifier Type: -
Identifier Source: org_study_id
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