Bipolar I disorder MedDRA version: 12.0 Level: PT Classification code 10004939 Term: Bipolar I disorder
Conditions
Interventions
Product Name: Cariprazine
Product Code: RGH-188
Pharmaceutical Form: Capsule*
Current Sponsor code: RGH-188
Other descriptive name: Cariprazine
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Forest Research Institute, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in the study, patients must have either documented inadequate response or be intolerant to their current treatment or not be currently receiving any treatment, and they also must meet the following criteria: Criteria to be assessed at Visit 1 (Screening): 1. Provide written (signed or thumbprinted) informed consent before the initiation of any study-specific procedures 2. Male or female, 18 to 65 years of age, inclusive 3. Currently meet the DSM-IV-TR criteria for bipolar I disorder confirmed by the administration of the Structured Clinical Interview (SCID), most recent episode manic or mixed type—with or without psychotic symptoms 4. Young Mania Rating Scale (YMRS) total score = 18 5. Montgomery-Asberg Depression Rating Scale (MADRS) score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Principal DSM-IV-TR–based diagnosis of an axis I disorder, other than bipolar I, or any axis I disorder other than bipolar I that was the primary focus of treatment within 6 months before V1 2. Currently meet DSM-IV-TR criteria for any of the following: • Mental retardation, delirium, dementia, amnesic, or other cognitive disorders • Schizophrenia, schizoaffective, or other psychotic disorders • Rapid cycling (>4 episodes of a mood disturbance in the previous 12 months that meets criteria for major depressive, manic, mixed, or hypomanic episodes per DSM-IV) • Substance-induced manic or hypomanic episode. Mania that is a result of direct psychological effects of a general medical condition • 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 • Alcohol and/or substance abuse or dependence (other than nicotine or caffeine) within the prior 3 months. 3. Positive result from the blood alcohol test or urine drug screen for any prohibited Medication 4. History of intolerance or hypersensitivity to cariprazine, other drugs of the same class, rescue medications or any history of severe drug allergy or hypersensitivity. 5. Experiencing first manic episode 6. At imminent risk of injuring self or others or causing significant damage to property, as judged by the PI 7. Suicide risk, as determined by any of the following criteria: • A suicide attempt within the past year • A score of 5 or greater on item 10 of the MADRS • Significant risk judged by the PI based on the psychiatric interview or information collected in the C-SSRS 8. Manic symptoms resulting from initiation of prior antidepressant therapy 9. Electroconvulsive therapy in the 3 months prior to V1 10. Treatment with depot neuroleptic in the 3 months prior to V1 11. Treatment with clozapine in the past 10 years (exception: episodic use of clozapine at doses = 100 mg/d for the treatment of insomnia) 12. Previous resistance to electroconvulsive therapy 13. Requiring concomitant treatment with any of the prohibited medications, supplements, or herbal medications listed in Protocol App. II 14. Female patients who meet the following criteria: Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study. Not at least 2 years postmenopausal, surgically sterile, or practicing a reliable method of contraception that will continue throughout the study duration. In Germany: not at least 2 years postmenopausal, surgically sterile, or practicing a highly reliable (Pearl Index <1) method of contraception that will continue throughout the study duration. Refer to protocol section 9.3.2, EC #14 for acceptable methods of contraception in Germany. 15. Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being 16. Any cardiovascular disease that is clinically significant, unstable, or decompensated. Refer to protocol section 9.3.2., EC #16. 17. Hypothyroidism or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 3 months before V1 18. Abnormal level of serum vitamin B12 or folate, or psychiatric symptoms possibly secondary to any other organic medical condition 19. Gastric bypass or have any condition that would be expected to affect drug absorption 20. History of seizur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.;Secondary Objective: ;Primary end point(s): Collection of long term safety data, including adverse events, ECGs, laboratory parameters and ophthalmology information. | — |
Countries
Germany, Hungary, Spain
Outcome results
None listed