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Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone 20, 40, 60 mg | Experimental | Lurasidone 20, 40, or 60 mg/day flexibly dosed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) | Percentage of subjects with treatment emergent adverse events (TEAEs) | 12 Weeks |
| Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) | Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs) | 12 Weeks |
| Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) | Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs) | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores | Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity. |
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Inclusion Criteria:
Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).
Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Exclusion Criteria:
Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).
Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Psychiatry Pharmaceutical Studies, Inc | Birmingham | Alabama | 35226 | United States | ||
| Synergy Clinical Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone 20, 40, 60 mg | Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline to12 Weeks |
| Change From Baseline to Week 12 (LOCF) in CGI-S Score | The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. | baseline to week 12 |
| Change From Baseline to Week 12 (LOCF) in the YMRS Total Score | The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania. | Baseline to week 12 |
| Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score | The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety. | Baseline to week 12 |
| Change From Baseline to Week 12 (LOCF) in the SDS Total Score | The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired). | Baseline to week 12 |
| Escondido |
| California |
| 92025 |
| United States |
| Collaborative Neuro Science Network, Inc. | Garden Grove | California | 92845 | United States |
| Stanford -VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | United States |
| Florida Clinical Research Center, LLC | Sarasota | Florida | 34201 | United States |
| Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders | Boston | Massachusetts | 02114 | United States |
| St. Charles Psychiatric Associates/Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Village Clinical Research Inc. | New York | New York | 10003 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Behavioral Medical Research of Staten Island | Staten Island | New York | 10305 | United States |
| Psychiatry and Behavioral Sciences, Duke | Durham | North Carolina | 27705 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | United States |
| CRI Worldwide - Kirkbride | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Dept. of Psychiatry, UT Southwestern Medical Center | Dallas | Texas | 75390-8849 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone 20, 40, 60 mg | Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) | Percentage of subjects with treatment emergent adverse events (TEAEs) | Safety population | Posted | Number | percentage of subjects | 12 Weeks |
|
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| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores | Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity. | Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF). | Posted | Mean | Standard Deviation | units on a scale | Baseline to12 Weeks |
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| ||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs) | Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs) | Safety Population | Posted | Number | percentage of subjects | 12 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) | Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs) | Safety Population | Posted | Number | percentage of subjects | 12 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 (LOCF) in CGI-S Score | The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. | Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF) | Posted | Mean | Standard Deviation | units on a scale | baseline to week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 (LOCF) in the YMRS Total Score | The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania. | Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score | The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety. | Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 (LOCF) in the SDS Total Score | The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired). | Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 12 |
|
|
12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lurasidone 20, 40, 60 mg | Lurasidone 20, 40, or 60 mg/day flexibly dosed Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed | 0 | 48 | 16 | 48 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed.
In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 1-866-503-6351 | Sunovion | 1-866-503-6351 | clinicaltrialdisclosure@sunvion.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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