Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients with Schizophrenia

• Conditions: Schizophrenia is a lifelong disabling psychiatric disorder with a reported worldwide prevalence of about 1%.; MedDRA version: 12.1Level: LLTClassification code 10001064Term: Acute schizophrenia

• Registration Number: EUCTR2010-018405-12-LT
• Lead Sponsor: Forest Research Institute, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Written (signed or thumbprinted) informed consent obtained from the patient before the initiation of any study specific procedures
2. Written (signed or thumbprinted) informed consent obtained from the caregiver before the initiation of any study-specific procedures
3. Male or female inpatient, 18 to 60 years of age, inclusive
4. Current diagnosis of schizophrenia according to DSM-IV-TR criteria (295.30 Paranoid Type, 295.10 Disorganized Type, 295.20 Catatonic Type, or 295.90 Undifferentiated Type) as determined by the Structured Clinical Interview for DSM IV (new patients only)
5. Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (new patients only)
6. Completion of the double-blind treatment period in one of the lead-in studies (RGH MD-04 or RGH-MD-05) (except new patients)
7. PANSS positive syndrome subscale total score (PANSS items P1 to P7) = 25
8. CGI-S score = 3
9. Patients who are eligible to continue as outpatients in the opinion of the Principal Investigator
10. Negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test (applies to female patients of childbearing potential only)
11. Normal physical examination findings, vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
12. Body mass index between 18 and 40 kg/m2, inclusive
13. A designated caregiver who will accompany the patient at each visit (If a caregiver cannot attend a visit, written documentation from the caregiver of the patient’s study medication compliance will need to be provided.)
14. Patients must be able to speak and understand the local language sufficiently to understand the nature of the study
15. Caregivers must be able to speak and understand the local language sufficiently to understand the nature of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Currently meeting DSM-IV-TR criteria for any of the following:
• Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
• Bipolar I and II disorder
• Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
• Known or suspected borderline or antisocial personality disorder or other DSM IV-TR axis II disorder of sufficient severity to interfere with participation in this study
• Substance abuse or dependence (other than nicotine or caffeine) within the 3 months prior to Visit 1 of this study (new patients only)
2. Patients in their first episode of psychosis
3. Treatment-resistant schizophrenia over the last 2 years
4. Positive result from the blood alcohol test or from the urine drug screen (UDS) for any prohibited medication
5. History of intolerance or hypersensitivity to other drugs of the same class as cariprazine or to rescue medications, or any history of severe drug allergy or hypersensitivity
7. Suicide risk
8. Electroconvulsive therapy in the 3 months before Visit 1 of this study (new patients only)
9. Previous lack of response to electroconvulsive therapy
10. Treatment with a depot neuroleptic less than 1 cycle in duration before Visit 1 (new patients only)
11. Treatment with clozapine in the past 10 years (see protocol for exceptions)
12. Requiring concomitant treatment with any of the prohibited medications, supplements, or herbal products listed in protocol Appendix II (see protocol)
13. At Visit 2, requiring pharmacologic treatment for the control of EPS (new patients only)
14. Patients who have extrapyramidal symptoms that are not adequately controlled by anti-EPS medications in the opinion of the PI at Visit 1 (RGH-MD-04 or RGH-MD-05 completers only)
15. Patients who in the opinion of the PI, are experiencing ongoing, uncontrolled, clinically significant adverse events at Visit 1 (RGH-MD-04 or RGH-MD-05 completers only)
16. Prior participation in any investigational study of RGH-188 (cariprazine), except for patients who participated in RGH-MD-04 or RGH-MD-05
17. Women who meet the following criteria:
• Pregnant, breastfeeding, and/or planning to become pregnant and/or breastfeed during the study
• Not at least 2 years postmenopausal, surgically sterile, or practicing a reliable method of contraception that will continue for the duration of the study.
19. Any cardiovascular disease that is clinically significant, unstable, or decompensated. Other excluding conditions are detailed in the protocol.
20. Hypo- or hyperthyroidism, unless stabilized
21. Abnormally low level of vitamin B-12 or folate or psychiatric symptoms possibly secondary to any other organic medical condition
23. History of seizure disorder, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes the patient toward a risk for seizure
24. Known history of cataracts or presence of any of the following Lens Opacities Classification System III (LOCS III) findings at the screening examination:
• Nuclear opalescence (LOCS III NO) > 4
• Nuclear color (LOCS III NC) > 4
• Cortical cataract (LOCS III C) > 3
• Posterior subcapsular cataract (LOCS III P) > 0.5
25. Patients who meet any of the following LOCS III assessment criteria:
• History of intraocular surgery or laser treatment
• History or current findings of ocular disease (open- or narrow-angle glaucoma, retinopathies, corneal diseases)
• Allergies to dilating drops,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia;Secondary Objective: NA;Primary end point(s): Adverse Events