Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients (CARPZ-01)
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|ClinicalTrials.gov Identifier: NCT04771299|
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : April 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder Cognitive Impairment||Drug: Cariprazine Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Cariprazine in Improving Cognitive Functioning in Euthymic Patients With Bipolar I Disorder: A Proof of Concept Randomized, Double Blind Placebo Controlled Trial|
|Actual Study Start Date :||July 7, 2021|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||September 30, 2026|
Active Comparator: Cariprazine
1.5mg of Cariprazine added to their current treatment for 6 week period
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.
Other Name: VRAYLAR®
Placebo Comparator: Placebo
Matching placebo added to their current treatment for 6 week period.
Placebo is an inactive substance that looks identical to the study medication that contains no therapeutic ingredient.
- Improvement in cognitive performance [ Time Frame: 6 weeks ]The primary efficacy measure will be improvement in cognitive performance, as measured by changes in composite cognitive score from baseline to endpoint, extracted from the International Society for Bipolar Disorders-Battery for Assessment of Neurocognition. The higher the scores the better the outcome.
- Improvement in functioning [ Time Frame: 6 weeks ]The co-primary efficacy measure will include changes in functioning from baseline to endpoint measured using UCSD based performance skills assessment-brief version. The higher the scores the better the outcome.
- Change in depression [ Time Frame: 6 weeks ]Montgomery Asberg Depression Rating Scale will be used to assess changes in bipolar depression from baseline to endpoint. Lower scores reflect better clinical outcomes.
- Change in Mania [ Time Frame: 6 weeks ]The Young Mania Rating Scale will be used to assess changes in mania from baseline to endpoint. The higher the scores means worsening in Mania. Lower scores reflect better clinical outcomes.
- Improvement in overall psychiatric status [ Time Frame: 6 weeks ]Clinical Global Improvement Scale will be used to assess change from baseline to endpoint in overall psychiatric status. The higher the scores means worsening in psychiatric status .
- Improvement in Quality of Life [ Time Frame: 6 weeks ]Quality of Life, Bipolar Version Scale will be used to assess improvement in quality of life from baseline to endpoint. Higher scores reflect better outcomes.
- Improvement in Subjective-rated Cognitive Functioning [ Time Frame: 6 weeks ]Cognitive Complaints in Bipolar Disorder Rating Assessment will be used to assess changes in subjective cognitive functioning from baseline to endpoint. Lower scores mean better outcomes.
- Improvement in Objectively Rated Daily Functioning [ Time Frame: 6 weeks ]Functioning Assessment Short Test will be used to assess improvement in objectively rated daily functioning, defined as change in scores from baseline to endpoint. Higher scores mean better outcomes.
- Improvement in Subjectively Rated Daily Functioning [ Time Frame: 6 weeks ]Sheehan Disability Scale (SDS) will be used to assess improvement in subjectively rated daily functioning, defined as change in scores from baseline to endpoint. Lower scores mean better outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771299
|Contact: Jayasree Basivireddy, PhDfirstname.lastname@example.org|
|Contact: Nazlin Walji, B.Scemail@example.com|
|Canada, British Columbia|
|Djavad Mowfaghian Centre for Brain Heath||Recruiting|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Contact: Jayasree Basivireddy, PhD 604-822-3769 Jayasree.firstname.lastname@example.org|
|Contact: Nazlin Walji, B.Sc,CCRC 604-822-7294 email@example.com|
|Principal Investigator: Lakshmi Yatham, MBBS,MRCPsyc|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 3K7|
|Contact: VICTORIA Tran, MSc 647-200-9924 firstname.lastname@example.org|
|Principal Investigator: Benicio N Frey, MD, MSc, PhD|
|Principal Investigator:||Lakshmi N Yatham, MBBS,MRCPsyc||University of British Columbia, Department of Psychiatry, BC|