A Long-Term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder

Conditions: Bipolar I disorder
MedDRA version: 12.0Level: PTClassification code 10004939Term: Bipolar I disorder

Registration Number: EUCTR2009-016041-25-DE

Lead Sponsor: Forest Research Institute, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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 < 18
6. Experienced a manic or mixed episode that required treatment within 12 months of
Visit 1
7. If a female with childbearing potential, have a negative serum ß-human chorionic
gonadotropin (ß-hCG) pregnancy test
8. Have normal physical examination results, vital signs, clinical laboratory test results,
and electrocardiogram (ECG) results or abnormal results that are judged not clinically
significant by the Investigator and documented as such in the eCRF.
9. Body mass index (BMI) between 18 and 40 kg/m2, inclusive
Criteria to be assessed at Visit 2 (Baseline):
10. Continue to meet the Visit 1 inclusion criteria
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. 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