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Trial record 1 of 1 for:    NCT02731612
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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 : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Nazlin Walji, University of British Columbia

Tracking Information
First Submitted Date  ICMJE March 23, 2016
First Posted Date  ICMJE April 7, 2016
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE May 8, 2017
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: lurasidone
    Atypical Antipsychotic
    Other Name: Latuda
  • Other: Placebo
    Inactive substance
Study Arms  ICMJE
  • Experimental: Lurasidone
    Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.
    Intervention: Drug: lurasidone
  • Placebo Comparator: Placebo
    Placebo added to current treatment for 6 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nazlin Walji, B.Sc 604-822-7294 nazlin.walji@ubc.ca
Contact: Jayasree Basivireddy, PhD 604-822-3769 jayasree.basivireddy@ubc.ca
Listed Location Countries  ICMJE Canada,   Japan,   United Kingdom,   United States
Removed Location Countries Spain
 
Administrative Information
NCT Number  ICMJE NCT02731612
Other Study ID Numbers  ICMJE H16-00129
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nazlin Walji, University of British Columbia
Study Sponsor  ICMJE Nazlin Walji
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lakshmi N Yatham, MBBS, FRCPC, MRCPsych (UK),MBA University of British Columbia, Department of Psychiatry
PRS Account University of British Columbia
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP