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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 : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Nazlin Walji, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: lurasidone Other: Placebo Phase 3

Study Design
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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 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Lurasidone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lurasidone
Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.
 Drug: lurasidone
Atypical Antipsychotic
Other Name: Latuda
Placebo Comparator: Placebo
Placebo added to current treatment for 6 weeks
 Other: Placebo
Inactive substance


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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 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
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Information from the National Library of Medicine

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


Contacts
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Contact: Nazlin Walji, B.Sc 604-822-7294 nazlin.walji@ubc.ca
Contact: Jayasree Basivireddy, PhD 604-822-3769 jayasree.basivireddy@ubc.ca

Locations
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United States, Massachusetts
The Brigham and Women's Hospital, Department of Psychiatry Recruiting
Boston, Massachusetts, United States, 02115
Contact: Megan Shanahan, MHS    617-732-5790    mshanahan2@bwh.harvard.edu   
Principal Investigator: Katherine Burdick, Ph.D         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nicole Moomaw, BA    216-844-2863    Nicole.Moomaw@UHhospitals.org   
Contact: Carla M Conroy, MPH    216.844.2871    Carla.Conroy@UHhospitals.org   
Principal Investigator: Keming Gao, MD         
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,         
Sponsors and Collaborators
Nazlin Walji
Investigators
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Principal Investigator: Lakshmi N Yatham, MBBS,MRCPsy University of British Columbia, Department of Psychiatry
More Information
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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: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nazlin Walji, University of British Columbia:
Bipolar Disorder
Cognition
Euthymic
Lurasidone
Additional relevant MeSH terms:
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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