Lurasidone for Cognitive Improvement in Bipolar Disorder (ELICE_BD Trial)
Palo Alto (17 mi)Overseen byLakshmi N Yatham, MBBS,MRCPsy
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Nazlin Walji
Stay on your current meds
Pivotal Trial (Near Approval)
Prior Safety Data
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.
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.12349
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 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.12589
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.12467
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
I am between 19 and 65 years old.
I have experienced at least 2 clear episodes of hypomania in the past 5 years.
I am a woman who has been postmenopausal for at least a year or am surgically sterile.
I am using or agree to use effective contraception or double barrier methods.
I am on medication for mood stabilization, like lithium or valproate.
I have been diagnosed with Bipolar Type I or II, with or without psychosis.
Exclusion Criteria
I have a psychotic disorder, but it's not Bipolar Disorder.
I have tried lurasidone before and it didn't work or caused side effects.
I am currently taking two or more antipsychotic medications.
I am currently taking medications such as clozapine or tricyclic antidepressants.
I or my family have heart issues, shown by abnormal EKG results.
I am not taking medications that increase dopamine or anticholinergics.
I have a history of serious brain injury or neurological issues affecting my thinking.
Treatment Details
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
UBC Mood Disorders CenterVancouver, Canada
The Brigham and Women's Hospital, Department of PsychiatryBoston, MA
University Hospitals Cleveland Medical CenterCleveland, OH
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Who is running the clinical trial?
Nazlin WaljiLead Sponsor
References
The effectiveness of lurasidone as an adjunct to lithium or divalproex in the treatment of bipolar disorder. [2015]The majority of patients with bipolar disorder spend a lot of time in depressive episodes that impose a great burden on patients, caregivers, and society and accounts for the largest part of the morbidity-mortality of the illness. Lurasidone is an atypical antipsychotic with a potent binding affinity as antagonist for D2, 5-HT2A, 5-HT7, and partial agonist at 5-HT1A receptors. Affinity for other receptors as H1 and muscarinic were negligible. Lurasidone was approved in 2010 for the treatment of schizophrenia and recently, 2013, for bipolar depression in monotherapy and an adjunct to lithium or valproate. Clinical trials have established that lurasidone adjuvant to lithium or valproate has more efficacy than the placebo and is associated with minimal weight gain and no clinically meaningful alterations in glucose, lipids, or the QT interval. Additional studies are desirable to know the clinical profile of lurasidone in long-term treatment, in patients with bipolar II disorders, and versus other antipsychotic agents.
Lurasidone: a review of its use in adult patients with bipolar I depression. [2018]Lurasidone (Latuda(®)), a benzisothiazole derivative antipsychotic, is approved in the USA and Canada for the treatment of adults with major depressive episodes (MDE) associated with bipolar I disorder; this article reviews studies of lurasidone in this indication. In two 6-week, placebo-controlled trials in adults with bipolar I depression, lurasidone 20-120 mg/day reduced depressive symptoms, either as monotherapy or as an adjunct to lithium or valproate. Lurasidone reduced the mean Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline (primary endpoint) by >50 %; the reductions in scores were significantly greater than with placebo. The treatment effects were small to medium and the numbers needed to treat to obtain an additional MDE response (≥50 % reduction from baseline in the MADRS total score) were ≤7 across the lurasidone groups. In a third, similarly designed trial of lurasidone 20-120 mg/day adjunctive to lithium or valproate, there was no significant between-group difference in the change in the mean MADRS total score at week 6 (primary endpoint), although significant differences favouring lurasidone were observed from week 2 to week 5. Across trials, the most frequently occurring adverse events included akathisia, extrapyramidal symptoms and somnolence. Lurasidone had a favourable profile with respect to weight gain and metabolic disturbances, known to occur with some other antipsychotics. Thus, lurasidone offers a valuable addition to the therapies available for adult patients with bipolar depression, either as monotherapy or as an adjunct to lithium or valproate.
Cost-effectiveness of lurasidone vs quetiapine extended-release (XR) in patients with bipolar depression. [2015]Bipolar disorder imposes a high economic burden on patients and society. Lurasidone and quetiapine extended-release (XR) are atypical antipsychotic agents indicated for monotherapy treatment of bipolar depression. Lurasidone is also indicated as adjunctive therapy with lithium or valproate for depressive episodes associated with bipolar disorder. The objective of this analysis was to estimate the cost-effectiveness of lurasidone and quetiapine XR in patients with bipolar depression.
Lurasidone versus treatment as usual for cognitive impairment in euthymic patients with bipolar I disorder: a randomised, open-label, pilot study. [2019]Cognitive impairment is present in euthymic patients with bipolar disorder and correlates with impairments in everyday functioning. We aimed to examine the efficacy of lurasidone adjunctive therapy compared with treatment as usual (TAU) in improving cognition.
Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. [2019]To evaluate the safety and effectiveness of 6 months of treatment with lurasidone in older adults with a diagnosis of bipolar I depression.
Longer-Term Effectiveness and Tolerability of Adjunctive Open Lurasidone in Patients With Bipolar Disorder. [2019]To retrospectively assess lurasidone effectiveness/efficacy/tolerability in bipolar disorder (BD) patients.
TULIP study: Trail of Lurasidone in bipolar disorder in Pakistan. [2022]This study examined usefulness and efficiency of Lurasidone in appraisal with the placebo as for the treatment of Bipolar Disorders.
[Using Lurasidone in the treatment of mental illness in childhood]. [2022]Lurasidone is one of the newest antipsychotics approved for use in childhood. The review presents generalized data on the pharmacological profile of Lurasidone, preclinical and clinical studies of the drug with an analysis of the parameters of pharmacodynamics, pharmacokinetics, clinical efficacy, tolerability and safety of therapy for schizophrenia and bipolar disorder in children. It also provides data on the off-lable use of Lurasidone in childhood for autism spectrum disorders, Tourette's syndrome, hypomania in the structure of bipolar affective disorder. The data on the efficacy of Lurasidone in a wide range of psychopathological disorders, including positive, negative, affective and cognitive domains, as well as a favorable tolerability profile of the drug, including long-term therapy, are presented.
The efficacy and safety of lurasidone in bipolar I depression with and without rapid cycling: A pooled post-hoc analysis of two randomized, placebo-controlled trials. [2023]The efficacy and safety of lurasidone monotherapy in patients with bipolar I depression with or without rapid cycling has not been previously investigated.