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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003819-31 | EudraCT Number |
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Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone 40mg | Experimental |
| |
| Lurasidone 80mg | Experimental |
| |
| Lurasidone 120mg | Experimental |
| |
| Sugar Pill | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone HCl | Drug | Once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGI-S From Baseline to the End of the Double-blind Treatment | Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). | 6 weeks |
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Inclusion Criteria:
To be eligible to enter the study, each patient must comply with the following inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K&S Professional Research Services, LLC. | Little Rock | Arkansas | 72201 | United States | ||
| Comprehensive Neuroscience, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23421963 | Result | Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17. | |
| 39144777 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone 40mg | Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cerritos |
| California |
| 90703 |
| United States |
| Clinical Innovations, Inc. | Costa Mesa | California | 92647 | United States |
| Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3 | Garden Grove | California | 92645 | United States |
| California Clinical Trials | Paramount | California | 90723 | United States |
| Pasadena Research Institute | Pasadena | California | 91107 | United States |
| California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road | Pico Rivera | California | 90660 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | United States |
| Comprehensive Neuroscience, Inc. | Washington D.C. | District of Columbia | 20016 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34208 | United States |
| Segal Institute for Clinical Research, Fidelity Clinical Research, Inc. | North Miami | Florida | 33161 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Alexian Brothers Health System | Hoffman Estates | Illinois | 60169 | United States |
| Lake Charles Clinical Trials LLC | Lake Charles | Louisiana | 70601 | United States |
| Booker, J. Gary, MD. APMC | Shreveport | Louisiana | 71104 | United States |
| Center for Behavioral Health, LLC | Rockville | Maryland | 20850 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Erie County Medical Center, Corp | Buffalo | New York | 14215 | United States |
| CRI Worldwide LLC at Kirkbride | Philadelphia | Pennsylvania | 19139 | United States |
| Research Strategies of Memphis, LLC. | Memphis | Tennessee | 38119 | United States |
| Future Search Trials of Neurology | Austin | Texas | 78756 | United States |
| Hospital Caremeau | Nîmes | 30000 | France |
| S V Medical College | Tirupati | Andh Prad | 517507 | India |
| Government Hospital for Mental Care | Visakhapatnam | Andh Prad | 530017 | India |
| Sheth Vadilal Sarabhai General Hospital | Ahmedabad | Gujarat | 380006 | India |
| Shanti Nursing Home | Aurangabad | Mahara | 431005 | India |
| Madras Medical College & Government General Hospital | Chennai | Tamil Nadu | 600003 | India |
| Deva Mental Health Care | Varanasi | Uttar Prad | 221005 | India |
| Hospital Permai | Johor Bahru | Johor | 81200 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Spitalul Clinic Judetean de Urgenta Arad | Arad | 310022 | Romania |
| Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos" | Bucharest | 030442 | Romania |
| Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia | Bucharest | 041914 | Romania |
| Centrul de Recuperare si Reabilitare Gura Ocnitei | Gura Ocniței | 130083 | Romania |
| Spitalul Judetean Arges | Piteşti | 110069 | Romania |
| North State Medical University | Arkhangelsk | 163060 | Russia |
| Republic Psychiatric Hospital | Karelia | 111111 | Russia |
| City Psychoneurological Dispensary #7 (with Hospital) | Saint Petersburg | 190005 | Russia |
| City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets | Saint Petersburg | 190121 | Russia |
| City Psychiatric Hospital #4 | Saint Petersburg | 191119 | Russia |
| Bekhterev Psychoneurological Research Institute | Saint Petersburg | 193019 | Russia |
| City Psychiatric Hospital #3 of Skvortsov-Stepanov | Saint Petersburg | 197341 | Russia |
| Dnipropetrovsk Regional Clinical Hospital named Mechnikov | Dnipropetrovsk | 49005 | Ukraine |
| Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy | Donetsk | 83037 | Ukraine |
| Kyiv City Clin. Psychoneurolog. Hosp.#1 | Kyiv | 04080 | Ukraine |
| Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp | Lviv | 79021 | Ukraine |
| Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1 | Odesa | 65006 | Ukraine |
| Kherson Regional Psychiatric Hospital | Vil. Stepanovka, Kherson | 73488 | Ukraine |
| Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan. |
| 34751928 | Derived | Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9. |
| 27048911 | Derived | Correll CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. doi: 10.1017/S1092852915000917. Epub 2016 Apr 6. |
| 24955752 | Derived | Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23. |
| FG001 | Lurasidone 80mg | lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
| FG002 | Lurasidone 120mg | Lurasidone 40 mg tablets taken once/day |
| FG003 | Placebo | Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone 40mg | Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug. |
| BG001 | Lurasidone 80mg | lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
| BG002 | Lurasidone 120mg | Lurasidone 40 mg tablets taken once/day |
| BG003 | Placebo | Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
| BG004 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | CGI-S From Baseline to the End of the Double-blind Treatment | Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). | The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population.All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement,were in the efficacy analysis in the treatment group to which they were randomized. | Posted | Oct 2010 | Least Squares Mean | 95% Confidence Interval | scores on a scale | 6 weeks |
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| Primary | Change in Total PANSS Score From Baseline to the End of the Double Blind Phase | The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. | The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized. | Posted | Oct 2010 | Least Squares Mean | 95% Confidence Interval | scores on a scale | 6 weeks |
|
14 days post study therapy
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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 40mg | Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug. | 2 | 124 | 96 | 124 | ||
| EG001 | Lurasidone 80mg | lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. | 3 | 121 | 90 | 121 | ||
| EG002 | Lurasidone 120mg | Lurasidone 40 mg tablets taken once/day | 6 | 124 | 106 | 124 | ||
| EG003 | Placebo | Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. | 5 | 127 | 85 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) |
| ||
| Staphylococcal Infection | Infections and infestations | MedDRA (10.0) |
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| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (10.0) |
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| Complex Partial Seizures | Nervous system disorders | MedDRA (10.0) |
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| Psychotic Disorders | Psychiatric disorders | MedDRA (10.0) |
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| Schizophrenia | Psychiatric disorders | MedDRA (10.0) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) |
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| Weight Increase | Investigations | MedDRA (10.0) |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
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| Akathisia | Nervous system disorders | MedDRA (10.0) |
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| Dystonia | Nervous system disorders | MedDRA (10.0) |
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| Headache | Nervous system disorders | MedDRA (10.0) |
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| Parkinsonism | Nervous system disorders | MedDRA (10.0) |
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| Sedation | Nervous system disorders | MedDRA (10.0) |
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| Somnolence | Nervous system disorders | MedDRA (10.0) |
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| Agitation | Psychiatric disorders | MedDRA (10.0) |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) |
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For multi-center studies, it is mandatory that the first publication is based on all data obtained from all analyses as stipulated in the protocol. Investigators participating in multicenter studies must agree not to present data gathered individually or by subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and also by DSP-Sepracor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josephine Cucchiaro | Sunovion Pharmaceuticals Inc. | 201-592-2050 | josephine.cucchiaro@sunovion.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic 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 |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| United States |
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| Malaysia |
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| Ukraine |
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| Romania |
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| Russian Federation |
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| India |
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| OG002 | Lurasidone 120mg | Lurasidone 40 mg tablets taken once/day |
| OG003 | Placebo | Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
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