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)

Lakshmi N Yatham9 sites in 4 countries100 target enrollmentMay 8, 2017

ConditionsBipolar Disorder

Interventionslurasidone Placebo

Drugslurasidone

Overview

Phase: Phase 3
Intervention: lurasidone
Conditions: Bipolar Disorder
Sponsor: Lakshmi N Yatham
Enrollment: 100
Locations: 9
Primary Endpoint: Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.

Registry

clinicaltrials.gov

Start Date

May 8, 2017

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lakshmi N Yatham

Responsible Party

Sponsor Investigator

Principal Investigator

Lakshmi N Yatham

Prinicipal Investigator

University of British Columbia

Eligibility Criteria

Inclusion Criteria

•Males or females aged 19 to 65 years inclusive.
•Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM.5) diagnosis of Bipolar Type I or Type II Disorder, with or without a history of psychosis. BP II patients must have had 2 definite periods of hypomania in the last 5 years.
•All patients must be taking either a mood stabilizer (i.e. lithium or valproate) (lamotrigine as a mood stabilizer is acceptable for bipolar 2 disorder patients only and not for bipolar I disorder) 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 atypical antipsychotics are excluded. Combinations of these medications as outlined above, or the combination of any of them with lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus asenapine 5-20 mg/day, are also permitted.
•All concomitant medication must be at a stable dose for two weeks prior to the randomization visit.
•Clinically stable during the last 4 weeks as assessed by clinical interview.
•A Montgomery Asberg Depression Rating Scale(MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to
•Patients who show cognitive impairments (-0.50 SD or below) on either the Wechsler Adult Intelligence Scale-IV (WAIS-IV) -Coding subtest, or the Rey Auditory Verbal Learning Test (RAVLT) total learning score on trials 1 to 5 or immediate recall, at screening visit.
•A WAIS-IV vocabulary scaled score \>5 (equivalent to estimated IQ 80 or greater).
•A sufficient level of the English or Japanese language.
•Females who are postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) or are surgically sterile.

Exclusion Criteria

•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.
•Patients taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, and cogentin.
•Those taking two or more antipsychotics.
•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.
•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 rTMS or tDCS or DBS within eight weeks or treatment with an experimental drug within 30 days.
•History of nonresponse or intolerance to lurasidone.
•Psychotic disorder other than Bipolar Disorder.
•Patients who currently meet criteria for anxiety disorder (GAD, OCD, Panic disorder, PTSD).

Arms & Interventions

Lurasidone

Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.

Intervention: lurasidone

Placebo

Placebo added to current treatment for 6 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy.

Time Frame: 6 weeks

Cognitive improvement will be measured by changes in composite cognitive score from baseline to endpoint, extracted from the International Society for Bipolar Disorders-Battery for Assessment of Neurocognition.