Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone HCl | Drug | 40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Proportions of subjects with AEs, SAEs, and discontinuations due to AEs. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289 | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K and S Professional Research Services | Little Rock | Arkansas | 72201 | United States | ||
| Synergy Clinical Research of Escondido |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24330868 | Result | Citrome L, Weiden PJ, McEvoy JP, Correll CU, Cucchiaro J, Hsu J, Loebel A. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014 Aug;19(4):330-9. doi: 10.1017/S109285291300093X. Epub 2013 Dec 16. | |
| 27245981 | Derived |
Not provided
Not provided
Not provided
FPI August 10, 2010-LPV November 28, 2011, locations were private health clinics, university hospitals, private research facilities.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open Label | Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Escondido |
| California |
| 92025 |
| United States |
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | United States |
| Pacific Research Partners, LLC | Oakland | California | 94612 | United States |
| California Clinical Trials | Paramount | California | 90723 | United States |
| Pasadena Research Institute | Pasadena | California | 91107 | United States |
| California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC | Pico Rivera | California | 90660 | United States |
| California Neuropsychopharmacology Clinical Research Institute (CNRI) | San Diego | California | 92102 | United States |
| University of California San Diego Medical Center | San Diego | California | 92103-8218 | United States |
| Collaborative Neuroscience Network, South Bay | Torrance | California | 90502 | United States |
| Western Affiliated Research Institute | Denver | Colorado | 80204 | United States |
| Comprehensive NeuroScience, Inc. | Atlanta | Georgia | 30328 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70601 | United States |
| St. Charles Psychiatric Associates - Midwest Research | Saint Charles | Missouri | 63301 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
| Duke University Dept. of Psychiatry | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| CRI Worldwide - Kirkbride Center | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Clinical Trials, LP | Austin | Texas | 78731 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| Pillar Clinical Research, LLC | Dallas | Texas | 75243 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Wharton Research Center | Wharton | Texas | 77488 | United States |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | United States |
| Awad G, Ng-Mak D, Rajagopalan K, Hsu J, Pikalov A, Loebel A. Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia. BMC Psychiatry. 2016 Jun 1;16:176. doi: 10.1186/s12888-016-0879-5. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | One enrolled subject did not receive any study medication and was excluded from this summary. | Number | participants |
|
| 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 | Adverse Events | Proportions of subjects with AEs, SAEs, and discontinuations due to AEs. | Safety population - One enrolled subject did not receive any study medication and was excluded from this summary. | Posted | Number | participants | 6 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy | Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289 | Not Posted | 6 months |
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label | Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary. | 8 | 148 | 47 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizoaffective Disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Schizophrenia | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Bipolar I Disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Homicidal Ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Paranoia | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Akathisia | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
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 following completion of study at all sites, the PI shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, CNS | Sunovion Pharmaceuticals Inc | 1-866-503-6351 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|