A randomised study to evaluate Lurasidone versus Placebo in improving cognitive functioning in patients with Bipolar Disorder

Phase 1

• Conditions: Euthymic Bipolar disorder; MedDRA version: 21.1Level: PTClassification code 10057667Term: Bipolar disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-002213-19-GB
• Lead Sponsor: niversity of British Columbia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-05
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients who meet all of the following criteria are eligible to participate in this trial:

1.Males or females aged 19 to 65 years inclusive.
2.DSM.5 diagnosis of Bipolar Type I or Type II Disorder, with or without a
history of Psychosis. Bipolar Type 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 (i.e. Lithium or
Valproate) (Lamotrigine as a mood stabilizer is acceptable for Bipolar II
disorder patients only and not for Bipolar I disorder) or an atypical
antipsychotic or a combination of these (two mood stabilizers or a mood
stabilizer plus an atypical antipsychotic), at therapeutic doses, for mood
stabilization. Those taking two atypical antipsychotics are excluded.
Medications and therapeutic doses are: lithium, serum level 0.6-1.2 mEq/L;
divalproex/sodium valproate, serum level 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 these medications as outlined above, or the combination of any of them with
lamotrigine 100-400 mg daily, 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 two weeks prior to the
randomization visit.
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-IV – 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.A WAIS-IV vocabulary scaled score >5 (equivalent to estimated IQ 80 or
greater).
9.A sufficient level of English or Spanish or Japanese language.
10.Females who are postmenopausal for at least 1 year before the screening visit
(confirmed by an FSH test) or are surgically sterile.
11.Females of childbearing potential who are taking contraceptive pills or agree
to practice effective 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.
12.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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Patients meeting any of the following criteria are not eligible to participate in the trial:

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.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.

5.Anticholinergics and stimulants that increase dopamine levels are not permitted
6.Cognitive remediation therapy within 3 months prior to entry or during the
double blind phase.
7.Neuromodulation treatment with ECT or rTMS or tDCS or DBS within eight weeks or
treatment with an experimental drug within 30 days.
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 childhood 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 clinical trial of medicinal product
• Study Design: Not specified