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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone | Experimental | Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks. |
|
| Placebo | Placebo Comparator | Placebo added to current treatment for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lurasidone | Drug | Atypical Antipsychotic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression | Montgomery Asberg Depression Rating Scale (MADRS) will be used to assess changes in bipolar depression from baseline to endpoint. | 6 weeks |
| Change in Mania | The Young Mania Rating Scale (YMRS) will be used to assess changes in mania from baseline to endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lakshmi N Yatham, MBBS,MRCPsy | University of British Columbia, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brigham and Women's Hospital, Department of Psychiatry | Boston | Massachusetts | 02115 | United States | ||
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Placebo | Other | Inactive substance |
|
| 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. | 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. | 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. | 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. | 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. | 6 weeks |
| University Hospitals Cleveland Medical Center |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| UBC Mood Disorders Center | Vancouver | British Columbia | V6T 1Z3 | Canada |
| Department of Psychiatry, University of Occupational and Environmental Health | Kitakyushu | Fukuoka | 807-8555 | Japan |
| Department of Neuropsychiatry, Kansai Medical University | Moriguchi-shi | Osaka | 570-8506 | Japan |
| Department of Psychiatry, Hokkaido University Graduate School of Medicine | Kita-ku | Sapporo | 060-8638 | Japan |
| National Center of Neurology and Psychiatry | Kodaira | Tokyo | 187-8551 | Japan |
| Department of Psychiatry, Fujita Health University School of Medicine | Aichi | Toyoake | 470-1192 | Japan |
| Institute of Psychiatry, Psychology and Neuroscience,King's College London | London | England | SE5 8AF | United Kingdom |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |