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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025167
Receipt No. R000028947
Scientific 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)
Date of disclosure of the study information 2016/12/07
Last modified on 2019/12/18

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Basic information
Public 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)
Acronym Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (ELICE_BD)
Scientific 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)
Scientific Title:Acronym Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (ELICE_BD)
Region
Japan North America Europe

Condition
Condition Bipolar Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study is to compare changes in cognitive function in euthymic bipolar patients who are treated with 20 to 80 mg/day of Lurasidone vs Placebo adjunctive therapy over a 6 week period.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The primary efficacy measure for the study will be improvement in cognitive performance, as measured by changes in composite cognitive score from baseline to endpoint, extracted from the International Society for Bipolar Disorders Battery for Assessment of Neurocognition. The co-primary efficacy measure will include changes in functioning from baseline to endpoint measured using UCSD-based performance skills assessment-brief version.
Key secondary outcomes Secondary efficacy measures will include: a) improvement in mood scores, based on Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS); b) improvement in overall psychiatric status, defined as change from baseline to endpoint in score on the Clinical Global Improvement Scale, Bipolar Version, Severity and Change Subscales; c) frequency and severity of side effects of lurasidone as reported by patients or determined by investigators; d) improvement in quality of life, defined as change from baseline to endpoint in scores on the Quality of Life, Bipolar Version, global and subscale ratings; e) improvement in subjective-rated cognitive functioning, defined as change from baseline to endpoint in scores on the cognitive complaints in bipolar disorder rating assessment (COBRA); f) improvement in daily functioning, defined as change from baseline to endpoint in scores on the Functioning Assessment Short Test (FAST), Sheehan Disability Scale (SDS); and g) study completion rates.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention group: Lurasidone 20 mg tablets, 6 weeks, daily oral administration starting at 20 mg, increasing to 40 mg at Day 7, and recommended to increase to 60 mg at Week 3 depending on the subject's performance on the WAIS-3 Coding subtest. The dose may be further increased to a maximum dose of 80 mg if there are no tolerability issues based on investigator's discretion.
Interventions/Control_2 Control group: matching placebo, 6 weeks, daily oral administration starting at 20 mg, increasing to 40 mg at Day 7, and recommended to increase to 60 mg at Week 3 depending on the subject's performance on the WAIS-3 Coding subtest. The dose may be further increased to a maximum dose of 80 mg if there are no tolerability issues based on investigator's discretion.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
19 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Aged 19 to 65 years.
2. DSM-5 BP I or II Disorder. 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 (lithium or valproate or lamotrigine) or an atypical antipsychotic or a combination of these in therapeutic doses except for two atypical antipsychotics. Medications and therapeutic doses are: lithium 0.6-1.2 mEq/L; divalproex/sodium valproate 350-700 mM/L(45-125 mcg/ml); lamotrigine 100-400mg/day; risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; and ziprasidone 80-160 mg/day. Combination of a mood stabilizer plus asenapine 5-20 mg/day is also permitted. Lamotrigine as a single agent therapy is only allowed for BP II patients.
4. All concomitant medication must be at a stable dose for 2 weeks prior to the randomization.
5. Clinically stable during the last 4 weeks as assessed by clinical interview.
6. A MADRS and YMRS score less than or equal to 8.
7. Patients who show cognitive impairments, defined as 0.5 SD below the mean or worse(z =-0.5 or lower), on either the WAIS-III-Coding subtest, or the Rey Auditory Verbal Learning Test total learning score on trials 1-5 or immediate recall trial, at screening visit.
8. WAIS-III vocabulary scaled score >5.
9. Sufficient level of Japanese language.
10. Females who are postmenopausal for at least 1 year before the screening visit (confirmed by FSH test) or are surgically sterile. Females of childbearing potential who are taking contraceptive pills or agree to practice 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.
11. Capable 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.
Key exclusion criteria Subjects meeting any of the following criteria are not eligible to participate in the trial:
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. Anticholinergics and stimulants that increase dopamine levels are not permitted
5. Cognitive remediation therapy within 3 months prior to entry or during the double blind phase.
6. Neuromodulation treatment with ECT or rTMS or tDCS or DBS within eight weeks or treatment with an experimental drug within 30 days.
7. 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.
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.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Lakshmi
Middle name
Last name Yatham
Organization University of British Columbia
Division name Regional Head and Program Medical Director, Mental Health and Addictions, Vancouver Coastal Health and Providence Health Care
Zip code V6T 2B5, CANADA
Address 2215 Wesbrook Mall Vancouver, British Columbia V6T 2B5, CANADA
TEL 604-822-0562
Email yatham@mail.ubc.ca

Public contact
Name of contact person
1st name Nazlin
Middle name
Last name Walji
Organization University of British Columbia
Division name Mood Disorders Centre at UBC Hospital UBC Department of Psychiatry
Zip code BC V6T 2A1
Address 2255 Wesbrook Mall Vancouver, BC V6T 2A1
TEL 604-822-7294
Homepage URL
Email nazlin.walji@ubc.ca

Sponsor
Institute University of British Columbia
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kazuyuki Nakagome (National Center of Neurology and Psychiatry Hospital; 4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551)
Name of secondary funder(s)

IRB Contact (For public release)
Organization NCNP Ethics Committee
Address 4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
Tel 042-341-2711
Email rinri-jimu@ncnp.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02731612
Org. issuing International ID_1 U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions British Columbia大学病院(British Columbia、Canada)、Mount Sinai病院(New York, USA)、Case Western Reserve大学病院(Ohio、USA)、Barcelona大学病院(Catalonia、Spain)、King's College大学病院(London、UK)、国立精神・神経医療研究センター病院(東京都)、北海道大学病院(北海道)、藤田医科大学病院(愛知県)、関西医科大学総合医療センター(大阪府)、産業医科大学病院(福岡県)、杏林大学医学部付属病院(東京都)、市ヶ谷ひもろぎクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 07 Day
Last modified on
2019 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028947

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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