Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (ELICE_BD)
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ClinicalTrials.gov Identifier: NCT02731612 |
Recruitment Status :
Recruiting
First Posted : April 7, 2016
Last Update Posted : November 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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Bipolar Disorder | Drug: lurasidone Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | May 8, 2017 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Lurasidone
Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.
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Drug: lurasidone
Atypical Antipsychotic
Other Name: Latuda |
Placebo Comparator: Placebo
Placebo added to current treatment for 6 weeks
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Other: Placebo
Inactive substance |
- 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.
- Change in Depression [ Time Frame: 6 weeks ]Montgomery Asberg Depression Rating Scale (MADRS) will be used to assess changes in bipolar depression from baseline to endpoint.
- Change in Mania [ Time Frame: 6 weeks ]The Young Mania Rating Scale (YMRS) will be used to assess changes in mania from baseline to endpoint.
- 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.
- 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.
- Improvement in Subjective-rated Cognitive Functioning [ Time Frame: 6 weeks ]Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) will be used to assess changes in subjective cognitive functioning from baseline to endpoint.
- Improvement in Objectively Rated Daily Functioning [ Time Frame: 6 weeks ]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.
- 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.

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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 |
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 8.
- 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.
- 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.
- 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:
- 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).
- Those with a current or lifetime diagnosis of ADHD or other learning disorders.
- Axis I diagnosis of alcohol/substance abuse or dependence within the past month.
- Significant risk of harm to self or others.
- Pregnancy or lactation.
- Liver function tests (AST and ALT) three times the upper limit of normal.

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): NCT02731612
Contact: Nazlin Walji, B.Sc | 604-822-7294 | nazlin.walji@ubc.ca | |
Contact: Jayasree Basivireddy, PhD | 604-822-3769 | jayasree.basivireddy@ubc.ca |
United States, Massachusetts | |
The Brigham and Women's Hospital, Department of Psychiatry | Active, not recruiting |
Boston, Massachusetts, United States, 02115 | |
United States, Ohio | |
University Hospitals Cleveland Medical Center | Active, not recruiting |
Cleveland, Ohio, United States, 44106 | |
Canada, British Columbia | |
UBC Mood Disorders Center | Recruiting |
Vancouver, British Columbia, Canada, V6T 1Z3 | |
Contact: Jayasree Basivireddy, PhD 604-822-3769 jayasree.basivireddy@ubc.ca | |
Contact: Nazlin Walji, BSc. 604-822-7294 nazlin.walji@ubc.ca | |
Principal Investigator: Lakshmi N Yatham | |
Japan | |
Department of Psychiatry, University of Occupational and Environmental Health | Recruiting |
Kitakyushu, Fukuoka, Japan, 807-8555 | |
Contact: Reiji Yoshimura, MD, Ph.D 81-93-603-1611 yoshi621@med.uoeh-u.ac.jp | |
Principal Investigator: Reiji Yoshimura, MD, Ph.D | |
Department of Neuropsychiatry, Kansai Medical University | Recruiting |
Moriguchi-shi, Osaka, Japan, 570-8506 | |
Contact: Masaki Kato, MD, Ph.D 81-6-6992-1001 masaaki-ogasa@ds-pharma.co.jp | |
Principal Investigator: Masaki Kato, MD, Ph.D | |
Department of Psychiatry, Hokkaido University Graduate School of Medicine | Recruiting |
Kita-ku, Sapporo, Japan, 060-8638 | |
Contact: Ichiro Kusumi, MD., Ph.D 81-11-706-5160 | |
Principal Investigator: Ichiro Kusumi, MD, Ph.D | |
National Center of Neurology and Psychiatry | Recruiting |
Kodaira, Tokyo, Japan, 187-8551 | |
Contact: Kazuyuki Nakagome, MD, Ph.D 81-42-341-2711 ext 6200 nakagome@guitar.ocn.ne.jp | |
Principal Investigator: Kazuyuki Nakagome, MD, Ph.D | |
Department of Psychiatry, Fujita Health University School of Medicine | Recruiting |
Aichi, Toyoake, Japan, 470-1192 | |
Contact: Nakao Iwata, MD, Ph.D 81-562-93-2000 | |
Principal Investigator: Nakao Iwata, MD, Ph.D | |
United Kingdom | |
Institute of Psychiatry, Psychology and Neuroscience,King's College London | Recruiting |
London, England, United Kingdom, SE5 8AF | |
Contact: Elliot Hampsey, MSc. elliot.hampsey@kcl.ac.uk | |
Contact: Andrea M Ulrichsen, MBBS andrea.ulrichsen@kcl.ac.uk | |
Principal Investigator: Allan Young, MB.ChB, Mphil, PhD, |
Principal Investigator: | Lakshmi N Yatham, MBBS,MRCPsy | University of British Columbia, Department of Psychiatry |
Responsible Party: | Nazlin Walji, Certified Clinical Research Coordinator, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT02731612 |
Other Study ID Numbers: |
H16-00129 |
First Posted: | April 7, 2016 Key Record Dates |
Last Update Posted: | November 2, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Bipolar Disorder Cognition Euthymic Lurasidone |
Bipolar Disorder Bipolar and Related Disorders Mental Disorders Lurasidone Hydrochloride Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Adrenergic alpha-2 Receptor Antagonists Adrenergic alpha-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents |