Status:
TERMINATED
Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients
Lead Sponsor:
Lakshmi N Yatham
Conditions:
Bipolar I Disorder
Cognitive Impairment
Eligibility:
All Genders
19-65 years
Phase:
PHASE3
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...
Detailed 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 conduc...
Eligibility Criteria
Inclusion
- Participant Inclusion Criteria Participants who meet all of the following criteria are eligible to participate in this trial.
- Males or females aged 19 to 65 years inclusive.
- DSM-5 diagnosis of Bipolar I Disorder, with or without a history of psychosis.
- 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.
- All concomitant medication must be at a stable dose for a minimum of two weeks prior to randomization.
- Clinically stable during the last 4 weeks, as assessed by clinical interview, prior to the randomization visit.
- A MADRS and YMRS score less than or equal to 8.
- 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.
- A WAIS-IV vocabulary scaled score ≥ 5 (equivalent to estimated IQ 80 or greater).
- A sufficient level of English language.
- Females who are postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) or are surgically sterile.
- 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.
- 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.
- 2 Participant Exclusion Criteria Participants meeting any of the following criteria are not eligible to participate in the trial.
- 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.
- Participants taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, benztropine, cogentin or lurasidone at screening visit.
- Those taking two or more antipsychotics.
- Anticholinergics and stimulants that increase dopamine levels are not permitted.
- Cognitive remediation therapy within 3 months prior to entry or during the double blind phase.
- Neuromodulation treatment with ECT or DBS within 8 weeks, or rTMS, tDCS or experimental drug treatment within 30days.
- History of nonresponse or intolerance to cariprazine.
- Psychiatric disorder other than bipolar disorder.
- Participants who currently meet criteria for anxiety disorder (GAD, OCD, panic disorder, PTSD).
- Those with a current or lifetime diagnosis of ADHD or other learning disorders.
- Those meeting DSM-5 criteria for alcohol or substance abuse or dependence disorder within the past month.
- Significant risk of harm to self or others.
- Those with severe personality disorders causing significant impairment in functioning.
- Pregnancy or lactation.
- Liver function tests (AST and ALT) three times the upper limit of normal.
- Contraindications to cariprazine according to prescribing information.
- Participants with increased risk or diagnosis of impulsive or compulsive behavior
Exclusion
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04771299
Start Date
July 7 2021
End Date
September 8 2024
Last Update
October 26 2024
Active Locations (1)
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1
Djavad Mowfaghian Centre for Brain Heath
Vancouver, British Columbia, Canada, V6T 1Z3