A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)
- Conditions
- Bipolar Disorder
- Registration Number
- JPRN-UMIN000025167
- Lead Sponsor
- niversity of British Columbia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Not provided
Subjects 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. Patients taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, and cogentin. 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 rTMS or tDCS or DBS within eight weeks or treatment with an experimental drug within 30 days. 7. Those taking strong CYP3A4 inhibitors (e.g. clarithromycin, nefazodone, grapefruit juice) or strong CYP3A4 inducers (e.g. carbamazepine, St John's wort (Hypericum perforatum). Please refer to the current Lurasidone SmPC for further listed contraindications. 8. History of nonresponse or intolerance to lurasidone. 9. Psychotic disorder other than Bipolar Disorder. 10. Patients who currently meet criteria for anxiety disorder (GAD, OCD, Panic disorder, PTSD). 11. Those with a documented childhood diagnosis of ADHD or other learning disorders. 12. Axis I diagnosis of alcohol/substance abuse or dependence within the past month. 13. Significant risk of harm to self or others. 14. Pregnancy or lactation. 15. Liver function tests (AST and ALT) three times the upper limit of normal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy measure for the study 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 co-primary efficacy measure will include changes in functioning from baseline to endpoint measured using UCSD-based performance skills assessment-brief version.
- Secondary Outcome Measures
Name Time Method Secondary efficacy measures will include: a) improvement in mood scores, based on Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS); b) improvement in overall psychiatric status, defined as change from baseline to endpoint in score on the Clinical Global Improvement Scale, Bipolar Version, Severity and Change Subscales; c) frequency and severity of side effects of lurasidone as reported by patients or determined by investigators; d) improvement in quality of life, defined as change from baseline to endpoint in scores on the Quality of Life, Bipolar Version, global and subscale ratings; e) improvement in subjective-rated cognitive functioning, defined as change from baseline to endpoint in scores on the cognitive complaints in bipolar disorder rating assessment (COBRA); f) improvement in daily functioning, defined as change from baseline to endpoint in scores on the Functioning Assessment Short Test (FAST), Sheehan Disability Scale (SDS); and g) study completion rates.