Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified January 2025 by Lakshmi N Yatham
Sponsor
Lakshmi N Yatham
Information Provided by (Responsible Party)
Lakshmi N Yatham
Clinicaltrials.gov Identifier
NCT02731612
Other Study ID Numbers:
H16-00129
First Submitted
March 22, 2016
First Posted
April 6, 2016
Last Update Posted
February 13, 2025
Last Verified
January 2025

ClinicalTrials.gov processed this data on February 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Bipolar Disorder
Drug: lurasidoneOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment100 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateMay 7, 2017
Actual Primary Completion DateDecember 30, 2024
Actual Study Completion DateDecember 30, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Lurasidone
Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.
Drug: lurasidone
Atypical Antipsychotic
Placebo
Placebo added to current treatment for 6 weeks
Other: Placebo
Inactive substance

Outcome Measures

Primary Outcome Measures
  1. Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy.
    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.
Secondary Outcome Measures
  1. Change in Depression
    Montgomery Asberg Depression Rating Scale (MADRS) will be used to assess changes in bipolar depression from baseline to endpoint.
  2. Change in Mania
    The Young Mania Rating Scale (YMRS) will be used to assess changes in mania from baseline to endpoint.
  3. Improvement in overall psychiatric status
    Clinical Global Improvement Scale will be used to assess change from baseline to endpoint in overall psychiatric status.
  4. Improvement in Quality of Life
    Quality of Life, Bipolar Version Scale will be used to assess improvement in quality of life from baseline to endpoint.
  5. Improvement in Subjective-rated Cognitive Functioning
    Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) will be used to assess changes in subjective cognitive functioning from baseline to endpoint.
  6. Improvement in Objectively Rated Daily Functioning
    Functioning Assessment Short Test (FAST) will be used to assess improvement in objectively rated daily functioning, defined as change in scores from baseline to endpoint.
  7. Improvement in Subjectively Rated Daily Functioning
    Sheehan Disability Scale (SDS) will be used to assess improvement in subjectively rated daily functioning, defined as change in scores from baseline to endpoint.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Males or females aged 19 to 65 years inclusive. 2. 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. 3. 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. 4. All concomitant medication must be at a stable dose for two weeks prior to the randomization visit. 5. Clinically stable during the last 4 weeks as assessed by clinical interview. 6. A Montgomery Asberg Depression Rating Scale(MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to 8. 7. 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. 8. A WAIS-IV vocabulary scaled score \>5 (equivalent to estimated IQ 80 or greater). 9. A sufficient level of the English or Japanese 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 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 dosing stops, or who agree to completely abstain from heterosexual intercourse. 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.
Exclusion Criteria
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. 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. 5. Anticholinergics and stimulants that increase dopamine levels are not permitted 6. Cognitive remediation therapy within 3 months prior to entry or during the double blind phase. 7. Neuromodulation treatment with ECT or rTMS or tDCS or DBS within eight weeks or treatment with an experimental drug within 30 days. 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 current or lifetime 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.

Contacts and Locations

Sponsors and CollaboratorsLakshmi N Yatham
Locations
The Brigham and Women's Hospital, Department of Psychiatry | Boston Massachusetts, United States, 02115University Hospitals Cleveland Medical Center | Cleveland Ohio, United States, 44106UBC Mood Disorders Center | Vancouver British Columbia, Canada, V6T 1Z3Department of Psychiatry, University of Occupational and Environmental Health | Kitakyushu Fukuoka, Japan, 807-8555Department of Neuropsychiatry, Kansai Medical University | Moriguchi-shi Osaka, Japan, 570-8506Department of Psychiatry, Hokkaido University Graduate School of Medicine | Kita-ku Sapporo, Japan, 060-8638National Center of Neurology and Psychiatry | Kodaira Tokyo, Japan, 187-8551Department of Psychiatry, Fujita Health University School of Medicine | Aichi Toyoake, Japan, 470-1192Institute of Psychiatry, Psychology and Neuroscience,King's College London | London England, United Kingdom, SE5 8AF
Investigators
Principal Investigator: Lakshmi N Yatham, MBBS,MRCPsy, University of British Columbia, Department of Psychiatry