Bipolar DisorderPhase 3ELICE_BDNCT02731612
Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients
A Phase 3 study testing lurasidone in people with Bipolar Disorder, run by Lakshmi N Yatham at 9 sites in 4 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- lurasidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 8 May 2017to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 19 to 65 years inclusive.
- Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM.5) diagnosis of Bipolar Type I or Type II Disorder, with or without a history of psychosis. BP II patients must have had 2 definite periods of hypomania in the last 5 years.
- All patients must be taking either a mood stabilizer (i.e. lithium or valproate) (lamotrigine as a mood stabilizer is acceptable for bipolar 2 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. 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.
- All concomitant medication must be at a stable dose for two weeks prior to the randomization visit.
- Clinically stable during the last 4 weeks as assessed by clinical interview.
- A Montgomery Asberg Depression Rating Scale(MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to 8.
Show all 12Show fewer
- Patients who show cognitive impairments (-0.50 SD or below) on either the Wechsler Adult Intelligence Scale-IV (WAIS-IV) -Coding subtest, or the Rey Auditory Verbal Learning Test (RAVLT) total learning score on trials 1 to 5 or immediate recall, at screening visit.
- A WAIS-IV vocabulary scaled score >5 (equivalent to estimated IQ 80 or greater).
- A sufficient level of the English or Japanese language.
- Females who are postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) or are surgically sterile.
- 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.
- 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.
Who cannot join
- 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.
- Patients taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, and cogentin.
- Those taking two or more antipsychotics.
- 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.
- Anticholinergics and stimulants that increase dopamine levels are not permitted
- Cognitive remediation therapy within 3 months prior to entry or during the double blind phase.
Show all 15Show fewer
- Neuromodulation treatment with ECT or rTMS or tDCS or DBS within eight weeks or treatment with an experimental drug within 30 days.
- History of nonresponse or intolerance to lurasidone.
- Psychotic disorder other than Bipolar Disorder.
- Patients who currently meet criteria for anxiety disorder (GAD, OCD, Panic disorder, PTSD).
- Those with a current or lifetime diagnosis of ADHD or other learning disorders.
- Axis I diagnosis of alcohol/substance abuse or dependence within the past month.
- Significant risk of harm to self or others.
- Pregnancy or lactation.
- Liver function tests (AST and ALT) three times the upper limit of normal.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Japan5 sites
Department of Psychiatry, Fujita Health University School of Medicine
Aichi, Toyoake, 470-1192
Department of Psychiatry, Hokkaido University Graduate School of Medicine
Kita-ku, Sapporo, 060-8638
Department of Psychiatry, University of Occupational and Environmental Health
Kitakyushu, Fukuoka, 807-8555
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
Department of Neuropsychiatry, Kansai Medical University
Moriguchi-shi, Osaka, 570-8506
United States2 sites
The Brigham and Women's Hospital, Department of Psychiatry
Boston, Massachusetts, 02115
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United Kingdom1 site
Institute of Psychiatry, Psychology and Neuroscience,King's College London
London, England, SE5 8AF
About this study
Official title: A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)
This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.
- Conditions
- Bipolar Disorder
- Being tested
- lurasidone, Placebo
- Keywords
- Bipolar Disorder, Cognition, Euthymic, Lurasidone
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lurasidoneDrug
Also called Latuda
Atypical Antipsychotic
PlaceboOther
Inactive substance
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Experimental | Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks. Receives: Drug: lurasidone |
| Placebo | Placebo comparator | Placebo added to current treatment for 6 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy.
Cognitive improvement will be measured by changes in composite cognitive score from baseline to endpoint, extracted from the International Society for Bipolar Disorders-Battery for Assessment of Neurocognition.
Measured: 6 weeks
Secondary outcomes (7)
Change in Depression
Montgomery Asberg Depression Rating Scale (MADRS) will be used to assess changes in bipolar depression from baseline to endpoint.
Measured: 6 weeks
Change in Mania
The Young Mania Rating Scale (YMRS) will be used to assess changes in mania from baseline to endpoint.
Measured: 6 weeks
Improvement in overall psychiatric status
Clinical Global Improvement Scale will be used to assess change from baseline to endpoint in overall psychiatric status.
Measured: 6 weeks
Improvement in Quality of Life
Quality of Life, Bipolar Version Scale will be used to assess improvement in quality of life from baseline to endpoint.
Measured: 6 weeks
Improvement in Subjective-rated Cognitive Functioning
Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) will be used to assess changes in subjective cognitive functioning from baseline to endpoint.
Measured: 6 weeks
Improvement in Objectively Rated Daily Functioning
Functioning Assessment Short Test (FAST) will be used to assess improvement in objectively rated daily functioning, defined as change in scores from baseline to endpoint.
Measured: 6 weeks
Improvement in Subjectively Rated Daily Functioning
Sheehan Disability Scale (SDS) will be used to assess improvement in subjectively rated daily functioning, defined as change in scores from baseline to endpoint.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start8 May 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakshmi N Yatham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lakshmi N Yatham, University of British Columbia
- Investigators
- Lakshmi N Yatham, MBBS,MRCPsy, Principal investigator, University of British Columbia, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731612
- Sponsor's protocol ID
- H16-00129
- Acronym
- ELICE_BD
- Status last verified
- Feb 2025
- First submitted
- 23 Mar 2016
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)
- ClinicalTrials.gov ID
- NCT02731612
- Acronym / sponsor ID
- ELICE_BD / H16-00129
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Cognition, Euthymic, Lurasidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lakshmi N YathamUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lurasidone | Experimental | Drug: lurasidoneLurasidone 20 - 80 mg / day added to current treatment for 6 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo added to current treatment for 6 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females aged 19 to 65 years inclusive.
- Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM.5) diagnosis of Bipolar Type I or Type II Disorder, with or without a history of psychosis. BP II patients must have had 2 definite periods of hypomania in the last 5 years.
- All patients must be taking either a mood stabilizer (i.e. lithium or valproate) (lamotrigine as a mood stabilizer is acceptable for bipolar 2 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. 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.
- All concomitant medication must be at a stable dose for two weeks prior to the randomization visit.
- Clinically stable during the last 4 weeks as assessed by clinical interview.
Key exclusion criteria (15 listed)
- 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.
- Patients taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, and cogentin.
- Those taking two or more antipsychotics.
- 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.
- Anticholinergics and stimulants that increase dopamine levels are not permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lurasidoneAlso: LatudaAtypical Antipsychotic | Drug | Lurasidone |
| PlaceboInactive substance | Other | Placebo |
Primary outcome
Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy.
Time frame: 6 weeks
Cognitive improvement will be measured by changes in composite cognitive score from baseline to endpoint, extracted from the International Society for Bipolar Disorders-Battery for Assessment of Neurocognition.
7 secondary outcomes
Change in Depression
Time frame: 6 weeks
Change in Mania
Time frame: 6 weeks
Improvement in overall psychiatric status
Time frame: 6 weeks
Improvement in Quality of Life
Time frame: 6 weeks
Improvement in Subjective-rated Cognitive Functioning
Time frame: 6 weeks
Improvement in Objectively Rated Daily Functioning
Time frame: 6 weeks
Improvement in Subjectively Rated Daily Functioning
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lakshmi N Yatham, MBBS,MRCPsy principal investigator
University of British Columbia, Department of Psychiatry
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lurasidone in people with Bipolar Disorder, run by Lakshmi N Yatham at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan, United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in cognitive performance in Euthymic bipolar patients treated with Lurasidone vs Placebo adjunctive therapy. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.