What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder, particularly atypical antipsychotics like Lurasidone, often have side effects including weight gain, metabolic syndrome, sedation, and extrapyramidal symptoms (such as tremors or rigidity). Mood stabilizers like lithium can cause tremors, increased thirst, diarrhea, and potential thyroid and kidney issues. Other second-generation antipsychotics, such as quetiapine and risperidone, may also lead to weight gain, sedation, and increased risk of diabetes. It is important to monitor these side effects and discuss them with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Several atypical antipsychotics have received FDA approval for the treatment of Bipolar Disorder, similar to Lurasidone, which modulates dopamine and serotonin receptors. These include Risperidone, Olanzapine, Quetiapine, Aripiprazole, and Ziprasidone. These medications are often used to manage manic, mixed, and depressive episodes associated with Bipolar Disorder. They work by affecting neurotransmitter pathways in the brain, particularly those involving dopamine and serotonin, to stabilize mood and reduce symptoms.

What other types of research exist?

Promising alternatives to Lurasidone for Bipolar Disorder treatment include Aripiprazole, Quetiapine, and Ziprasidone. These medications have shown efficacy in managing bipolar symptoms and are supported by recent clinical trials. Aripiprazole, in particular, has demonstrated benefits as an adjunctive therapy in patients with inadequate response to mood stabilizers. Quetiapine and Ziprasidone have also been effective in combination with mood stabilizers for long-term management.

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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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial is testing whether lurasidone can help improve thinking and memory in people with bipolar disorder who are currently stable but have cognitive problems. The medication works by balancing brain chemicals. Lurasidone has shown potential in improving thinking and memory in both schizophrenia and bipolar disorder.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Akathisia

Insomnia

Somnolence

Sedation

Dizziness

Panic Attack

Depression

100%

80%

60%

40%

20%

Study treatment Arm

Lurasidone Low Arm

Placebo

Lurasidone High Arm

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 13Eligibility criteria met

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.