Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients

  • STATUS
    Recruiting
  • End date
    Sep 30, 2026
  • participants needed
    30
  • sponsor
    Jayasree Basivireddy
Updated on 19 July 2021
Investigator
Jayasree Basivireddy, PhD.
Primary Contact
Djavad Mowfaghian Centre for Brain Heath (5.7 mi away) Contact
+1 other location

Summary

Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Cognitive deficits (significant cognitive impairments) in bipolar disorder are associated with impairments in everyday functioning and quality of life. Thus, improving cognitive functioning is an important treatment goal in people with bipolar disorder. In a recent study, investigators have demonstrated that lurasidone; an atypical antipsychotic was more effective than treatment as usual in improving cognition. The study will examine the efficacy of Cariprazine (VRAYLAR) in improving cognition in patients with bipolar disorder. Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. This study is a randomized (like the flip of a coin), double-blind (participant and the study team will not know which treatment arm participant will receive) study in which 30 participants will be randomized across two sites in Canada.

Description

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.

Details
Condition Cognitive Impairment, Bipolar I Disorder, Cognitive Dysfunction, Cognitive Impairments, neurocognitive disturbance
Treatment Placebo, cariprazine
Clinical Study IdentifierNCT04771299
SponsorJayasree Basivireddy
Last Modified on19 July 2021

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note