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Lurasidone for Cognitive Improvement in Bipolar Disorder (ELICE_BD Trial)
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.
ELICE_BD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELICE_BD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 505 Patients • NCT00868699ELICE_BD Trial Design
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- I have a psychotic disorder, but it's not Bipolar Disorder.I am between 19 and 65 years old.I have experienced at least 2 clear episodes of hypomania in the past 5 years.My current medications have been the same for the last two weeks.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 understand and can follow the study's requirements.I am on medication for mood stabilization, like lithium or valproate.I have tried lurasidone before and it didn't work or caused side effects.I am currently taking two or more antipsychotic medications.I have been diagnosed with Bipolar Type I or II, with or without psychosis.I am currently taking medications such as clozapine or tricyclic antidepressants.I have recently undergone cognitive therapy or brain stimulation treatment.I or my family have heart issues, shown by abnormal EKG results.I am not taking medications that increase dopamine or anticholinergics.My health has been stable for the last month.I have a history of serious brain injury or neurological issues affecting my thinking.
- Group 1: Lurasidone
- Group 2: Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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