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 current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone Open-Label Arm A | Experimental |
| |
| Lurasidone Open-Label Arm B | Experimental |
| |
| Lurasidone Open-Label Arm C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone HCl | Drug | Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse of Psychotic Symptoms During 6 Weeks | Relapse is defined as any occurrence of:
| 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and Safety | Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events | 6 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lurasidone 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 |
|---|---|---|---|
| 23473350 | Result | McEvoy JP, Citrome L, Hernandez D, Cucchiaro J, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study. J Clin Psychiatry. 2013 Feb;74(2):170-9. doi: 10.4088/JCP.12m07992. | |
| 24559217 | Derived |
Not provided
Not provided
Not provided
FPI June 24, 2010-LPV May 19, 2011, locations were private health clinics, university hospitals, private research facilities.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone Open-Label Arm 40/40 | Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg |
| FG001 | Lurasidone Open-Label Arm 40/80 | Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily |
| 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, LLC | Lake Charles | Louisiana | 70601 | United States |
| Saint Charles Psychiatric Associates/Midwest Research Group | 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 Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| CRI Worldwide - Kirkbride Center | Philadelphia | Pennsylvania | 19131 | 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 | 75390-8828 | United States |
| Wharton Research Center | Houston | Texas | 77488 | United States |
| University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84132 | United States |
| Awad G, Hassan M, Loebel A, Hsu J, Pikalov A, Rajagopalan K. Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia. BMC Psychiatry. 2014 Feb 23;14:53. doi: 10.1186/1471-244X-14-53. |
| FG002 | Lurasidone Open-Label Arm 80/80 | Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone Open-Label Arm 40/40 | Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg |
| BG001 | Lurasidone Open-Label Arm 40/80 | Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily |
| BG002 | Lurasidone Open-Label Arm 80/80 | Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 244 patients were randomized, 240 received study medication. | Count of Participants | Participants |
| |||||||||||||||
| Age Continuous | 244 patients were randomized, 240 received study medication. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | 244 patients were randomized, 240 received study medication. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | 244 patients were randomized, 240 received study medication. | 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 | Time to Relapse of Psychotic Symptoms During 6 Weeks | Relapse is defined as any occurrence of:
| Intend to treat | Posted | Mean | Standard Deviation | days | 6 Weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Tolerability and Safety | Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events | Posted | Number | participants | 6 Weeks |
|
|
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 | Lurasidone Open-Label Arm 40/40 | Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg | 3 | 72 | 45 | 72 | ||
| EG001 | Lurasidone Open-Label Arm 40/80 | Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily | 2 | 87 | 62 | 87 | ||
| EG002 | Lurasidone Open-Label Arm 80/80 | Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks | 0 | 81 | 59 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Alcoholism | Psychiatric disorders | Systematic Assessment |
| ||
| Schizoaffective disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Schizophrenia | Psychiatric disorders | Systematic Assessment |
| ||
| Sexually inappropriate behavior | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Akathisia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Sedation | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | 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 | 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
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|