Specific Procedures: If participant agrees to take part in this study, the procedures and visits include the following:
Screening Visit: (approximately 3.0 hours):Prior to any procedures being conducted, the Informed Consent Form will be reviewed with participant in detail and participant will have the opportunity to decide if s/he wish to participate in the study or not. If participant meets all the requirements and all of participants questions have been answered, participant will be asked to sign the consent form. A clinical assessment will take place, where participant will be asked questions about participants medical and psychiatric history including family psychiatric history and prior treatments. Participants medical records may be reviewed to confirm diagnosis and treatment history. The study doctor will complete rating scales to determine the current status of participants mood. Participant may choose not to answer any questions that participant is uncomfortable with. Neurocognitive tests (i.e., paper and pencil tests of memory, problem solving etc. as well as a computer component) will be conducted to determine if cognitive impairment exists. If there is no cognitive impairment no further procedures will be conducted. The information that is collected from the participant will not be used for any purpose other than stating how many people were screened for study participation. If cognitive impairment does exist, participant will be scheduled to return to the clinic within 4 weeks and a baseline visit will be completed. In addition to the above procedures, participant will also have a physical examination, which includes measurement of participants height, weight and blood pressure. To ensure safety of participation in the study, participant will be asked to have routine clinical blood work, including a pregnancy test for female participants of childbearing age, and a urine test for a drug screen. If participant has a personal or family history of significant cardiac problems or show cardiac abnormalities on the physical exam an EKG will be performed.
Baseline Visit (approximately 3-3.5 hours): At baseline, rating scales and clinical assessment will be completed to determine the current status of participants mood. Information about participants current medications and any side effects will be obtained. If participant is not eligible, participants will not be randomized into the study and no further procedures will be conducted.
If participant is eligible, participant will be randomized to receive either cariprazine or placebo in addition to participants current medications, and instructed on dosing. Participant will complete more neurocognitive testings. The use of benzodiazepines (Ativan, Lorazepam etc.) within 4 hours or caffeine intake 2 hours prior to neurocognitive testing is not allowed. Participant will be asked to complete questionnaires about participants functioning and quality of life. Vital signs and weight measurements will be obtained. Study medication will be dispensed to last until the next clinic visit. Participant must bring the remaining unused medication to the next appointment. Participant is asked to give 1.5 tablespoons (20 ml) of blood to analyze markers which may be predictive of bipolar disorder (biomarkers). Biomarkers are substances (like proteins, protein particles, or chemicals that make body function) that may be altered in those with bipolar disorder or may provide information about treatment response. These samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at the study site until they are sent for analysis at the end of the study.
Weeks 1, 2 and 4: (approximately 15 minutes each): Participant will be contacted by telephone to review any changes to participants medications and any side effects that may be experienced.
Week 3 Clinic appointment: (approximately 1 hour) : A clinical assessment will take place, where participant is asked questions about their mood. Information about participants current medications and any side effects will be obtained. Vital signs and weight measurements will be obtained. Bottle-1 of the study medication will be collected and bottle-2 of study medication will be dispensed. Participant will be asked to bring the remaining unused study medication from bottle-2 to the next clinic appointment. Participant will be asked to give a tablespoon (15 ml) of blood to test for levels of study medication. The samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at study site until they are sent for analysis at the end of the study.
Week 6/ Early Termination Visit: (approximately 3 hours): A clinical assessment will take place where participant will be asked questions about their mood. Neurocognitive testing will be administered to all participants who have had a minimum of 3 weeks of double- blind treatment. Participant is asked to complete some questionnaires about participants functioning and quality of life. Information about participants current medications and any side effects will be obtained. Vital signs and weight measurements will be obtained. Participant will have a physical examination and will be asked to complete routine laboratory tests including a pregnancy test for female participants of childbearing age, and a urine drug screen. In addition, participant is asked to give 2 tablespoons (30 ml) of blood to measure levels of study medication, and biomarkers. These samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at study site until they are sent for analysis at the end of the study.
Follow-up Telephone Assessment (2 weeks after study completion; approximately 15 minutes): Participant will be contacted by telephone to assess any side effects or issues post treatment.
