Schizophrenia Clinical Trial
Official title:
Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia
| Verified date | July 2019 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
| Status | Completed |
| Enrollment | 752 |
| Est. completion date | January 31, 2013 |
| Est. primary completion date | January 31, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures. - Patients currently meeting the 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), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID). - Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG). Exclusion Criteria: - Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia. |
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Forest Investigative Site 601 | Bello | Antioquia |
| Colombia | Forest Investigative Site 602 | Bogota | |
| Colombia | Forest Investigative Site 605 | Bogota | |
| Colombia | Forest Investigative Site 604 | Pereira | Risaralda |
| India | Forest Investigative Site 501 | Ahmedabad | |
| India | Forest Investigative Site 503 | Ahmedabad | |
| India | Forest Investigative Site 519 | Ahmedabad | |
| India | Forest Investigative Site 500 | Aurangabad | |
| India | Forest Investigative Site 507 | Kanpur | |
| India | Forest Investigative Site 518 | Lucknow | |
| India | Forest Investigative Site 515 | Mangalore | |
| India | Forest Investigative Site 517 | Mangalore | |
| India | Forest Investigative Site 510 | Mumbai | |
| India | Forest Investigative Site 513 | Nashik | |
| India | Forest Investigative Site 509 | Rajkot | |
| India | Forest Investigative Site 506 | Varanasi | |
| India | Forest Investigative Site 505 | Vijaywada | |
| Romania | Forest Investigative Site 306 | Bucuresti | |
| Romania | Forest Investigative Site 301 | Cluj-Napoca | |
| Romania | Forest Investigative Site 300 | Craiova | |
| Romania | Forest Investigative Site 311 | Craiova | |
| Romania | Forest Investigative Site 303 | Targoviste | |
| Romania | Forest Investigative Site 304 | Targu Mures | |
| Russian Federation | Forest Investigative Site 102 | Arkhangelsk | |
| Russian Federation | Forest Investigative Site 103 | Chelyabinsk | |
| Russian Federation | Forest Investigative Site 104 | Chita | |
| Russian Federation | Forest Investigative Site 108 | Saratov | |
| Russian Federation | Forest Investigative Site 110 | Saratov | |
| Russian Federation | Forest Investigative Site 105 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 106 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 107 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 109 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 112 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 113 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 100 | Tomsk | |
| Ukraine | Forest Investigative Site 205 | Dnipropetrovsk | |
| Ukraine | Forest Investigative Site 208 | Dnipropetrovsk | |
| Ukraine | Forest Investigative Site 200 | Donetsk | |
| Ukraine | Forest Investigative Site 211 | Glevakha | Kyiv Region |
| Ukraine | Forest Investigative Site 204 | Kharkiv | |
| Ukraine | Forest Investigative Site 203 | Kharkov | |
| Ukraine | Forest Investigative Site 206 | Kherson | Stepanivka |
| Ukraine | Forest Investigative Site 201 | Kyiv | |
| Ukraine | Forest Investigative Site 202 | Lviv | |
| Ukraine | Forest Investigative Site 209 | Poltava | |
| Ukraine | Forest Investigative Site 210 | Simferopol | |
| Ukraine | Forest Investigative Site 207 | Vinnytsya | |
| United States | Forest Investigative Site 055 | Atlanta | Georgia |
| United States | Forest Investigative Site 087 | Atlanta | Georgia |
| United States | Forest Investigative Site 074 | Austin | Texas |
| United States | Forest Investigative Site 078 | Bellevue | Washington |
| United States | Forest Investigative Site 002 | Bradenton | Florida |
| United States | Forest Investigative Site 080 | Carson | California |
| United States | Forest Investigative Site 040 | Cedarhurst | New York |
| United States | Forest Investigative Site 079 | Cerritos | California |
| United States | Forest Investigative Site 018 | Chicago | Illinois |
| United States | Forest Investigative Site 048 | Costa Mesa | California |
| United States | Forest Investigative Site 070 | Costa Mesa | California |
| United States | Forest Investigative Site 017 | Creve Coeur | Missouri |
| United States | Forest Investigative Site 084 | DeSoto | Texas |
| United States | Forest Investigative Site 007 | Flowood | Mississippi |
| United States | Forest Investigative Site 022 | Garden Grove | California |
| United States | Forest Investigative Site 083 | Garden Grove | California |
| United States | Forest Investigative Site 008 | Hoffman Estates | Illinois |
| United States | Forest Investigative Site 012 | Honolulu | Hawaii |
| United States | Forest Investigative Site 043 | Irving | Texas |
| United States | Forest Investigative Site 041 | Kissimmee | Florida |
| United States | Forest Investigative Site 052 | Las Vegas | Nevada |
| United States | Forest Investigative Site 021 | Little Rock | Arkansas |
| United States | Forest Investigative Site 072 | Little Rock | Arkansas |
| United States | Forest Investigative Site 086 | Little Rock | Arkansas |
| United States | Forest Investigative Site 050 | Long Beach | California |
| United States | Forest Investigative Site 071 | New Britain | Connecticut |
| United States | Forest Investigative Site 082 | North Miami | Florida |
| United States | Forest Investigative Site 006 | Oceanside | California |
| United States | Forest Investigative Site 047 | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site 077 | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site 003 | Riverside | California |
| United States | Forest Investigative Site 044 | Rockville | Maryland |
| United States | Forest Investigative Site 076 | Saint Charles | Missouri |
| United States | Forest Investigative Site 045 | Saint Louis | Missouri |
| United States | Forest Investigative Site 016 | San Diego | California |
| United States | Forest Investigative Site 073 | Santa Ana | California |
| United States | Forest Investigative Site 014 | Springdale | Arkansas |
| United States | Forest Investigative Site 004 | Willingboro | New Jersey |
| United States | Forest Investigative Site 019 | Willoughby | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories | Gedeon Richter Ltd. |
United States, Colombia, India, Romania, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline to Week 48 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 48 | |
| Secondary | Change From Baseline to Week 48 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 48 |
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