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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
Sponsor:
Information provided by (Responsible Party):
Jayasree Basivireddy, University of British Columbia

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Cognitive Impairment Drug: Cariprazine Other: Placebo Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cariprazine
1.5mg of Cariprazine added to their current treatment for 6 week period
 Drug: Cariprazine
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.
 Other: Placebo
Placebo is an inactive substance that looks identical to the study medication that contains no therapeutic ingredient.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 .

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participant Inclusion Criteria Participants who meet all of the following criteria are eligible to participate in this trial.

  1. Males or females aged 19 to 65 years inclusive.
  2. DSM-5 diagnosis of Bipolar I Disorder, with or without a history of psychosis.
  3. All patients must be taking either a mood stabilizer (i.e. lithium or valproate) or an atypical antipsychotic, or a combination of these (two mood stabilizers or a mood stabilizer plus an atypical antipsychotic), at therapeutic doses, for mood stabilization. Those taking two or more atypical antipsychotics are excluded. Medications and therapeutic doses are: lithium, serum level 0.6-1.2 mEq/L; divalproex/sodium valproate, serum level 350-700 mM/L (45-125 mcg/ml); risperidone 1-6 mg/day; olanzapine 5-20 mg/day; quetiapine IR or XR 300-800 mg/day; aripiprazole 10-30 mg/day; asenapine 5-20 mg/day, or ziprasidone 80-160 mg/day.
  4. All concomitant medication must be at a stable dose for a minimum of two weeks prior to randomization.
  5. Clinically stable during the last 4 weeks, as assessed by clinical interview, prior to the randomization visit.
  6. A MADRS and YMRS score less than or equal to 8.
  7. Patients who show cognitive impairments, defined as 0.5 standard deviations below the mean or worse (Z = -0.5 or lower), on either the WAIS-IV Coding subtest, or the RAVLT total learning score on trials 1-5 or immediate recall trial, at screening visit.
  8. A WAIS-IV vocabulary scaled score ≥ 5 (equivalent to estimated IQ 80 or greater).
  9. A sufficient level of English language.
  10. Females who are postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) or are surgically sterile.
  11. Females of childbearing potential who are taking contraceptive pills or agree to practice highly effective double barrier methods of contraception, from the time of signing the informed consent up to the last dose of study drug, and for 7 days after the last dose. Abstinence will only be considered an adequate form of contraception if it is the usual and preferred method.
  12. Capability of understanding, consenting to, and complying with study requirements, study visits, and to return to the clinic for follow-up evaluations as specified by the protocol.

4.2 Participant Exclusion Criteria Participants meeting any of the following criteria are not eligible to participate in the trial.

  1. A history of unstable or inadequately treated medical illnesses including moderate to severe brain injury, or neurological illnesses impacting cognitive function. Patients with a personal or family history of cardiac problems will need to undergo EKG at screen visit, and will be excluded if results are abnormal.
  2. Participants taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, benztropine, cogentin or lurasidone at screening visit.
  3. Those taking two or more antipsychotics.
  4. Anticholinergics and stimulants that increase dopamine levels are not permitted.
  5. Cognitive remediation therapy within 3 months prior to entry or during the double blind phase.
  6. Neuromodulation treatment with ECT or DBS within 8 weeks, or rTMS, tDCS or experimental drug treatment within 30days.
  7. History of nonresponse or intolerance to cariprazine.
  8. Psychiatric disorder other than bipolar disorder.
  9. Participants who currently meet criteria for anxiety disorder (GAD, OCD, panic disorder, PTSD).
  10. Those with a current or lifetime diagnosis of ADHD or other learning disorders.
  11. Those meeting DSM-5 criteria for alcohol or substance abuse or dependence disorder within the past month.
  12. Significant risk of harm to self or others.
  13. Those with severe personality disorders causing significant impairment in functioning.
  14. Pregnancy or lactation.
  15. Liver function tests (AST and ALT) three times the upper limit of normal.
  16. Contraindications to cariprazine according to prescribing information.
  17. Participants with increased risk or diagnosis of impulsive or compulsive behavior
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jayasree Basivireddy, PhD 6048223769 jayasree.basivireddy@ubc.ca
Contact: Nazlin Walji, B.Sc 604-822-7294 nazlin.walji@ubc.ca

Locations
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Canada, British Columbia
Djavad Mowfaghian Centre for Brain Heath Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Jayasree Basivireddy, PhD    604-822-3769    Jayasree.basivrieddy@ubc.ca   
Contact: Nazlin Walji, B.Sc,CCRC    604-822-7294    nazlin.walji@ubc.ca   
Principal Investigator: Lakshmi Yatham, MBBS,MRCPsyc         
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 3K7
Contact: VICTORIA Tran, MSc    647-200-9924    victran@stjosham.on.ca   
Principal Investigator: Benicio N Frey, MD, MSc, PhD         
Sponsors and Collaborators
Jayasree Basivireddy
Investigators
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Principal Investigator: Lakshmi N Yatham, MBBS,MRCPsyc University of British Columbia, Department of Psychiatry, BC
More Information
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Responsible Party: Jayasree Basivireddy, Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT04771299    
Other Study ID Numbers: H20-01293
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jayasree Basivireddy, University of British Columbia:
Bipolar I Disorder
Euthymia
Cariprazine
Cognition
Memory
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cariprazine
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs