Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients (ELICE_BD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02731612|
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: lurasidone Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.
Other Name: Latuda
Placebo Comparator: Placebo
Placebo added to current treatment for 6 weeks
- 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.
- Change in Depression [ Time Frame: 6 weeks ]Montgomery Asberg Depression Rating Scale (MADRS) will be used to assess changes in bipolar depression from baseline to endpoint.
- Change in Mania [ Time Frame: 6 weeks ]The Young Mania Rating Scale (YMRS) will be used to assess changes in mania from baseline to endpoint.
- Improvement in overall psychiatric status [ Time Frame: 6 weeks ]Clinical Global Improvement Scale will be used to assess change from baseline to endpoint in overall psychiatric status.
- Improvement in Quality of Life [ Time Frame: 6 weeks ]Quality of Life, Bipolar Version Scale will be used to assess improvement in quality of life from baseline to endpoint.
- Improvement in Subjective-rated Cognitive Functioning [ Time Frame: 6 weeks ]Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) will be used to assess changes in subjective cognitive functioning from baseline to endpoint.
- Improvement in Objectively Rated Daily Functioning [ Time Frame: 6 weeks ]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.
- Improvement in Subjectively Rated Daily Functioning [ Time Frame: 6 weeks ]Sheehan Disability Scale (SDS) will be used to assess improvement in subjectively rated daily functioning, defined as change in scores from baseline to endpoint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731612
|Contact: Nazlin Walji, B.Scfirstname.lastname@example.org|
|Contact: Jayasree Basivireddy, PhDemail@example.com|
|United States, Massachusetts|
|The Brigham and Women's Hospital, Department of Psychiatry||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Megan Shanahan, MHS 617-732-5790 firstname.lastname@example.org|
|Principal Investigator: Katherine Burdick, Ph.D|
|United States, Ohio|
|University Hospitals Cleveland Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Nicole Moomaw, BA 216-844-2863 Nicole.Moomaw@UHhospitals.org|
|Contact: Carla M Conroy, MPH 216.844.2871 Carla.Conroy@UHhospitals.org|
|Principal Investigator: Joseph R Calabrese, MD|
|Canada, British Columbia|
|UBC Mood Disorders Center||Recruiting|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Contact: Jayasree Basivireddy, PhD 604-822-3769 email@example.com|
|Contact: Nazlin Walji, BSc. 604-822-7294 firstname.lastname@example.org|
|Principal Investigator: Lakshmi N Yatham|
|Department of Psychiatry, University of Occupational and Environmental Health||Recruiting|
|Kitakyushu, Fukuoka, Japan, 807-8555|
|Contact: Reiji Yoshimura, MD, Ph.D 81-93-603-1611 email@example.com|
|Principal Investigator: Reiji Yoshimura, MD, Ph.D|
|Department of Neuropsychiatry, Kansai Medical University||Recruiting|
|Moriguchi-shi, Osaka, Japan, 570-8506|
|Contact: Masaki Kato, MD, Ph.D 81-6-6992-1001 firstname.lastname@example.org|
|Principal Investigator: Masaki Kato, MD, Ph.D|
|Department of Psychiatry, Hokkaido University Graduate School of Medicine||Not yet recruiting|
|Kita-ku, Sapporo, Japan, 060-8638|
|Contact: Ichiro Kusumi, MD., Ph.D 81-11-706-5160|
|Principal Investigator: Ichiro Kusumi, MD, Ph.D|
|National Center of Neurology and Psychiatry||Recruiting|
|Kodaira, Tokyo, Japan, 187-8551|
|Contact: Kazuyuki Nakagome, MD, Ph.D 81-42-341-2711 ext 6200 email@example.com|
|Principal Investigator: Kazuyuki Nakagome, MD, Ph.D|
|Department of Psychiatry, Fujita Health University School of Medicine||Not yet recruiting|
|Aichi, Toyoake, Japan, 470-1192|
|Contact: Nakao Iwata, MD, Ph.D 81-562-93-2000|
|Principal Investigator: Nakao Iwata, MD, Ph.D|
|Institute of Psychiatry, Psychology and Neuroscience,King's College London||Not yet recruiting|
|London, England, United Kingdom, SE5 8AF|
|Contact: Viktoriya Nikolova, BSc MRes 07795401682 firstname.lastname@example.org|
|Principal Investigator: Allan Young, MB.ChB, Mphil, PhD,|
|Principal Investigator:||Lakshmi N Yatham, MBBS, FRCPC, MRCPsych (UK),MBA||University of British Columbia, Department of Psychiatry|