Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (ELICE-BD)
- Conditions
- Bipolar Disorder
- Registration Number
- JPRN-jRCTs031180065
- Lead Sponsor
- akagome Kazuyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Males or females aged 19 to 65 years.
2. DSM-5 diagnosis of BP I or II Disorder. BP II patients must have had 2 definite periods of hypomania in the last 5 years.
3. All patients must be taking either a mood stabilizer (lithium or valproate) (lamotrigine for BP II only) or an atypical antipsychotic or a combination of these except for two atypical antipsychotics. Medications and therapeutic doses are: lithium, 0.6-1.2 mEq/L; divalproex/sodium valproate, 350-700 mM/L(45-125 mcg/ml); risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; and ziprasidone 80-160 mg/day. Combinations of any of them with lamotrigine 100-400 m/day, or the combination of a mood stabilizer plus asenapine 5-20 mg/day, are also permitted.
4. All concomitant medication must be at a stable dose for 2 weeks prior to the randomization.
5. Clinically stable during the last 4 weeks as assessed by clinical interview.
6. A MADRS and YMRS score less than or equal to 8.
7. Patients who show cognitive impairments, defined as 0.5 standard deviations below the mean or worse(z = - 0.5 or lower), on either the WAIS-III - Coding subtest, or the Rey Auditory Verbal Learning Test(RAVLT) total learning score on trials 1-5 or immediate recall trial, at screening visit.
8. WAIS-III vocabulary scaled score >6 (equivalent to estimated IQ 80 or greater).
9. Sufficient level of Japanese language.
10. Females who are postmenopausal for at least 1 year before the screening visit (confirmed by FSH test) or are surgically sterile. Females of childbearing potential who are taking contraceptive pills or agree to practice double barrier methods of contraception, from the time of signing the informed consent up to the last dose of study drug, and for 7 days after dosing stops, or who agree to completely abstain from heterosexual intercourse.
11. Capability of understanding, consenting to, and complying with study requirements, study visits, and to return to the clinic for follow-up evaluations as specified by the protocol.
1. A history of unstable or inadequately treated medical illnesses including moderate to severe brain injury, or neurological illnesses impacting cognitive function. Patients with a personal or family history of cardiac problems will need to undergo EKG at screen visit, and will be excluded if results are abnormal.
2. Patients taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, and cogentin.
3. Those taking two or more antipsychotics.
4. Anticholinergics and stimulants that increase dopamine levels are not permitted.
5. Cognitive remediation therapy within 3 months prior to entry or during the double blind phase.
6. Neuromodulation treatment with ECT or rTMS or tDCS or DBS within eight weeks or treatment with an experimental drug within 30 days.
7. Those taking strong CYP3A4 inhibitors (e.g. clarithromycin, nefazodone, grapefruit juice) or strong CYP3A4 inducers (e.g. carbamazepine, St John's wort (Hypericum perforatum). Please refer to the current Lurasidone SmPC for further listed contraindications.
8. History of nonresponse or intolerance to lurasidone.
9. Psychotic disorder other than Bipolar Disorder.
10. Patients who currently meet criteria for anxiety disorder (GAD, OCD, Panic disorder, PTSD).
11. Those with a documented current or lifetime diagnosis of ADHD or other learning disorders.
12. Axis I diagnosis of alcohol/substance abuse or dependence within the past month.
13. Significant risk of harm to self or others.
14. Pregnancy or lactation.
15. Liver function tests (AST and ALT) three times the upper limit of normal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method