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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

ELICE_BD Trial 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.

ELICE_BD Trial 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.

ELICE_BD Trial 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
17%
Nausea
11%
Akathisia
9%
Headache
7%
Insomnia
7%
Somnolence
7%
Sedation
6%
Dizziness
1%
Restless Leg Syndrome
1%
HIV Infection
1%
Subcutaneous Absceses
1%
Depression
1%
Panic Attack
1%
Foot Fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lurasidone High Arm
Lurasidone Low Arm

ELICE_BD 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To your knowledge, what other scientific research has been done on lurasidone?

"Right now, 5 separate clinical trials are underway for lurasidone. 2 of those trials have reached Phase 3. The majority of research locations for lurasidone are in Dallas, Texas; though, there are 27 research centres in total running these tests."

Answered by AI

Do people over the age of 55 qualify for this research study?

"According to the eligibility requirements posted, adults aged 19 to 65 are welcome to apply for this clinical trial. There are 24 other trials available for minors and 117 for seniors."

Answered by AI

What are the possible negative consequences of taking lurasidone?

"Lurasidone is deemed safe by our team at Power, receiving a 3 on our safety scale. This is because lurasidone is in Phase 3 of clinical trials, so there is some evidence of both efficacy and safety."

Answered by AI

What is different about this particular clinical trial?

"Lurasidone has been under clinical trial since 2014, when Otsuka America Pharmaceutical first sponsored a study. Since the original 200-person Phase 4 drug approval study in 2014, there have been 5 more lurasidone trials in 24 different cities and 4 countries."

Answered by AI

Who else is applying?

What site did they apply to?
The Brigham and Women's Hospital, Department of Psychiatry
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Want to learn more about the disease.
PatientReceived 2+ prior treatments
~15 spots leftby Dec 2024