Lurasidone for Cognitive Improvement in Bipolar Disorder
(ELICE_BD Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial requires that you stay on your current mood stabilizer or atypical antipsychotic at a stable dose for two weeks before randomization. However, you cannot take certain medications like procognitive drugs, clozapine, tricyclic antidepressants, or strong CYP3A4 inhibitors and inducers.
What data supports the idea that the drug Lurasidone for Cognitive Improvement in Bipolar Disorder is an effective treatment?
The available research shows that Lurasidone is effective in treating bipolar disorder, particularly in reducing depressive symptoms. In studies, Lurasidone was compared to a placebo and showed a significant reduction in depression scores, with more than 50% improvement in some cases. It was also noted for having fewer side effects like weight gain compared to other similar drugs. However, specific data on cognitive improvement in bipolar disorder is limited, and more research is needed to confirm its effectiveness in this area.12345
What safety data is available for lurasidone in treating bipolar disorder?
Lurasidone has been studied in various clinical trials for its safety and efficacy in treating bipolar disorder. It is approved for use in adults with bipolar I depression, either as monotherapy or as an adjunct to lithium or valproate. Clinical trials have shown that lurasidone is associated with minimal weight gain and no significant changes in glucose, lipids, or the QT interval. Common adverse events include akathisia, extrapyramidal symptoms, and somnolence. It has a favorable safety profile compared to some other antipsychotics, particularly regarding weight gain and metabolic disturbances. Long-term safety data in older adults and children also suggest a favorable tolerability profile.23678
Is the drug Lurasidone a promising treatment for improving cognition in people with bipolar disorder?
Yes, Lurasidone is a promising drug for improving cognition in people with bipolar disorder. It has shown effectiveness in reducing depressive symptoms and has a favorable safety profile, with minimal weight gain and no significant changes in glucose or lipids. It can be used alone or with other medications like lithium or valproate.12369
Research Team
Lakshmi N Yatham, MBBS,MRCPsy
Principal Investigator
University of British Columbia, Department of Psychiatry
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Lurasidone (Atypical Antipsychotic)
- Placebo (Other)
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Who Is Running the Clinical Trial?
Lakshmi N Yatham
Lead Sponsor
Nazlin Walji
Lead Sponsor