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Lurasidone for Cognitive Improvement in Bipolar Disorder (ELICE_BD Trial)

Phase 3
Recruiting
Led By Lakshmi N Yatham, MBBS,MRCPsy
Research Sponsored by Nazlin Walji
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females aged 19 to 65 years inclusive
BP II patients must have had 2 definite periods of hypomania in the last 5 years
Must not have
Psychotic disorder other than Bipolar Disorder
History of nonresponse or intolerance to lurasidone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial is testing whether lurasidone can improve cognition in people with bipolar disorder who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled and randomized to receive either lurasidone or placebo for 6 weeks.

Who is the study for?
Adults aged 19-65 with Bipolar I or II Disorder in remission, who are on stable mood stabilizers or antipsychotics, and show cognitive impairment. They must understand English or Japanese, have an IQ over 80, and not be at risk of self-harm. Women must use effective contraception or be postmenopausal.Check my eligibility
What is being tested?
The study is testing if Lurasidone improves thinking abilities in bipolar patients compared to a placebo. Participants will either receive Lurasidone or a dummy pill for six weeks while their cognitive functions are monitored.See study design
What are the potential side effects?
Lurasidone may cause side effects like drowsiness, restlessness, nausea, agitation and anxiety. It can also affect blood sugar levels and cholesterol but individual reactions vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 19 and 65 years old.
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I have experienced at least 2 clear episodes of hypomania in the past 5 years.
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I am a woman who has been postmenopausal for at least a year or am surgically sterile.
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I am using or agree to use effective contraception or double barrier methods.
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I am on medication for mood stabilization, like lithium or valproate.
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I have been diagnosed with Bipolar Type I or II, with or without psychosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a psychotic disorder, but it's not Bipolar Disorder.
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I have tried lurasidone before and it didn't work or caused side effects.
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I am currently taking two or more antipsychotic medications.
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I am currently taking medications such as clozapine or tricyclic antidepressants.
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I or my family have heart issues, shown by abnormal EKG results.
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I am not taking medications that increase dopamine or anticholinergics.
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I have a history of serious brain injury or neurological issues affecting my thinking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy.
Secondary outcome measures
Change in Depression
Change in Mania
Improvement in Objectively Rated Daily Functioning
+4 more

Side effects data

From 2012 Phase 3 trial • 505 Patients • NCT00868699
14%
Headache
10%
Nausea
8%
Akathisia
5%
Insomnia
4%
Somnolence
3%
Sedation
2%
Dizziness
1%
Panic Attack
1%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lurasidone Low Arm
Placebo
Lurasidone High Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LurasidoneExperimental Treatment1 Intervention
Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo added to current treatment for 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurasidone
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Atypical antipsychotics, such as Lurasidone, are commonly used to treat Bipolar Disorder by modulating dopamine and serotonin receptors. This mechanism helps to stabilize mood by balancing neurotransmitter activity, which is often dysregulated in individuals with Bipolar Disorder. By reducing the frequency and severity of manic and depressive episodes, these medications significantly improve the overall functioning and quality of life for patients.

Find a Location

Who is running the clinical trial?

Nazlin WaljiLead Sponsor
Lakshmi N Yatham, MBBS,MRCPsyPrincipal InvestigatorUniversity of British Columbia, Department of Psychiatry

Media Library

lurasidone Clinical Trial Eligibility Overview. Trial Name: NCT02731612 — Phase 3
Bipolar Disorder Research Study Groups: Lurasidone, Placebo
Bipolar Disorder Clinical Trial 2023: lurasidone Highlights & Side Effects. Trial Name: NCT02731612 — Phase 3
lurasidone 2023 Treatment Timeline for Medical Study. Trial Name: NCT02731612 — Phase 3
~8 spots leftby Dec 2024