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

Sponsor
Lakshmi N Yatham
Study ID
NCT04771299
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    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.
  • Placebo — OTHER
    Placebo is an inactive substance that looks identical to the study medication that contains no therapeutic ingredient.

Study Details

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.

Key Dates

Start date
Jul 7, 2021
Status verified
Oct 2024
Primary completion
Sep 8, 2024
Completion
Sep 8, 2024

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cariprazine
    1.5mg of Cariprazine added to their current treatment for 6 week period
  • Placebo Comparator: Placebo
    Matching placebo added to their current treatment for 6 week period.

Primary Outcome Measure

Improvement in cognitive performance [ Time Frame: 6 weeks ]

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