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

Sponsor

Nazlin Walji (Other)

Overall Status

Recruiting

CT.gov ID

NCT02731612

Collaborator

(none)

150

Enrollment

Locations

Arms

66.8

Anticipated Duration (Months)

16.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Lurasidone

Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.

Drug: lurasidone

Atypical Antipsychotic

Other Names:

Latuda

Placebo Comparator: Placebo

Placebo added to current treatment for 6 weeks

Other: Placebo

Inactive substance

Outcome Measures

Primary Outcome Measures

Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy. [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

Change in Depression [6 weeks]
Montgomery Asberg Depression Rating Scale (MADRS) will be used to assess changes in bipolar depression from baseline to endpoint.
Change in Mania [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Brigham and Women's Hospital, Department of Psychiatry	Boston	Massachusetts	United States	02115
2	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
3	UBC Mood Disorders Center	Vancouver	British Columbia	Canada	V6T 1Z3
4	Department of Psychiatry, University of Occupational and Environmental Health	Kitakyushu	Fukuoka	Japan	807-8555
5	Department of Neuropsychiatry, Kansai Medical University	Moriguchi-shi	Osaka	Japan	570-8506
6	Department of Psychiatry, Hokkaido University Graduate School of Medicine	Kita-ku	Sapporo	Japan	060-8638
7	National Center of Neurology and Psychiatry	Kodaira	Tokyo	Japan	187-8551
8	Department of Psychiatry, Fujita Health University School of Medicine	Aichi	Toyoake	Japan	470-1192
9	Institute of Psychiatry, Psychology and Neuroscience,King's College London	London	England	United Kingdom	SE5 8AF