Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

Schizophrenia Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694707
• Other study ID #: RGH-MD-16
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2008
• Est. completion date: August 31, 2009

Study information

• Verified date: May 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Other known NCT identifiers

• NCT00892528

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: August 31, 2009
• Est. primary completion date: August 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female, 18 to 60 years of age.

• Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).

• Total Positive and Negative Syndrome Scale (PANSS) score = 80 and = 120.

• Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

• Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.

• First episode of psychosis.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Placebo
Placebo was supplied in capsules.
• Cariprazine
Cariprazine was supplied in capsules
• Risperidone
Risperidone was supplied in capsules

Locations

Country	Name	City	State
India	Forest Investigative Site	Ahmedabad	Gujarat
India	Forest Investigative Site	Ahmedabad	Gujarat
India	Forest Investigative Site	Bangalore	Karna
India	Forest Investigative Site	Bangalore	Karna
India	Forest Investigative Site	Chennai	Tamilnadu
India	Forest Investigative Site	Chennai	Tamilnadu
India	Forest Investigative Site	Jaipur	Rajasthan
India	Forest Investigative Site	Kanpur	Uttar Prad
India	Forest Investigative Site	Mangalore	Karna
India	Forest Investigative Site	Mangalore	Karna
India	Forest Investigative Site	Manipal	Karna
India	Forest Investigative Site	Mysore	Karna
India	Forest Investigative Site	Pune	Mahara
India	Forest Investigative Site	Tirupati	Tamilnadu
India	Forest Investigative Site	Vijaywada	Andh Prad
India	Forest Investigative Site	Visakhapatnam	Andh Prad
Malaysia	Forest Investigative Site	Ipoh	Perak
Malaysia	Forest Investigative Site	Johor Bahru	Johor
Malaysia	Forest Investigative Site	Kota Bharu	Kelantan
Malaysia	Forest Investigative Site	Lembah Pantai	Kuala Lumpur
Malaysia	Forest Investigative Site	Ulu Kinta	Perak
Russian Federation	Forest Investigative Site	Arkhangelsk
Russian Federation	Forest Investigative Site	Gatchina
Russian Federation	Forest Investigative Site	Kazan
Russian Federation	Forest Investigative Site	Moscow
Russian Federation	Forest Investigative Site 1	Moscow
Russian Federation	Forest Investigative Site 2	Moscow
Russian Federation	Forest Investigative Site	Nizhniy Novgorod
Russian Federation	Forest Investigative Site	Samara
Russian Federation	Forest Investigative Site	St. Petersburg
Russian Federation	Forest Investigative Site	St. Petersburg
Russian Federation	Forest Investigative Site	St. Petersburg
Russian Federation	Forest Investigative Site	St. Petersburg
Russian Federation	Forest Investigative Site	St. Petersburg
Russian Federation	Forest Investigative Site 2	St. Petersburg
Russian Federation	Forest Investigative Site1	St. Petersburg
Ukraine	Forest Investigative Site	Chernigiv
Ukraine	Forest Investigative Site	Dnipropetrovsk	Dnipropetrovsk Oblast
Ukraine	Forest Investigative Site	Donetsk	Donetsk Oblast
Ukraine	Forest Investigative Site	Glevakha	Kyiv Oblast
Ukraine	Forest Investigative Site	Kharkiv	Kharkiv Oblast
Ukraine	Forest Investigative Site	Kherson, Vil. Stepanivka
Ukraine	Forest Investigative Site	Kiev
Ukraine	Forest Investigative Site	Kyiv	Kyiv Oblast
Ukraine	Forest Investigative Site	Kyiv	Kyiv Oblast
Ukraine	Forest Investigative Site	Odessa	Odessa Oblast
Ukraine	Forest Investigative Site	Ternopil	Ternopil Oblast
United States	Forest Investigative Site	Baltimore	Maryland
United States	Forest Investigative Site	Bradenton	Florida
United States	Forest Investigative Site	Bridgeton	Missouri
United States	Forest Investigative Site	Charleston	South Carolina
United States	Forest Investigative Site	Cincinnati	Ohio
United States	Forest Investigative Site	Costa Mesa	California
United States	Forest Investigative Site	Flowood	Mississippi
United States	Forest Investigative Site	Houston	Texas
United States	Forest Investigative Site	Houston	Texas
United States	Forest Investigative Site	Irving	Texas
United States	Forest Investigative Site	Kissimmee	Florida
United States	Forest Investigative Site	Lake Charles	Louisiana
United States	Forest Investigative Site	Long Beach	California
United States	Forest Investigative Site	Memphis	Tennessee
United States	Forest Investigative Site	Oceanside	California
United States	Forest Investigative Site	Paramount	California
United States	Forest Investigative Site	Riverside	California
United States	Forest Investigative Site	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  India,  Malaysia,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 6 in the PANSS Total Score	The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.	Baseline to Week 6
Secondary	Change From Baseline to Week 6 in the CGI-S Score	The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.	Baseline to Week 6