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A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia
Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone | Experimental | 80 mg AM dosing once daily |
|
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | 80 mg AM dosing once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score | The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores | The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia. |
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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 |
|---|---|---|---|---|---|---|
| Birmingham Psychiatry Pharmaceutical | Birmingham | Alabama | 35209 | United States | ||
| Summit Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19497249 | Result | Nakamura M, Ogasa M, Guarino J, Phillips D, Severs J, Cucchiaro J, Loebel A. Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Jun;70(6):829-36. doi: 10.4088/JCP.08m04905. Epub 2009 Jun 2. | |
| 39144777 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone 80 mg | 2 40 mg lurasidone tablets taken once/day |
| FG001 | Placebo | Matching placebo to lurasidone 40 mg tablets taken once/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Matching Placebo to 40mg lurasidone tablets |
|
| Baseline and 6 weeks |
| Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores | The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Baseline and 6 weeks |
| Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores | The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. | Baseline and 6 weeks |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Comprehensive NeuroScience | Cerritos | California | 90703 | United States |
| Collaborative Neuro Science Network, Inc. | Garden Grove | California | 92845 | United States |
| Optimum Health Services | La Mesa | California | 91942 | United States |
| California Clinical Trials | San Diego | California | 92123 | United States |
| CNRI, LLC San Diego | San Diego | California | 92126 | United States |
| Pacific Clinical Research | Upland | California | 91786 | United States |
| Comprehensive NeuroScience, Inc | Washington D.C. | District of Columbia | 20016 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| The Segal Institute | North Miami | Florida | 33161 | United States |
| University of South Florida, Department of Psychiatry and Behavioral Medicine | Tampa | Florida | 33613 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Comprehensive Neuroscience, Inc. | Hoffman Estates | Illinois | 60194 | United States |
| Robert Lynn Horne, MD, Suite 4 | Las Vegas | Nevada | 89102 | United States |
| CNS Research Institute | Clementon | New Jersey | 08021 | United States |
| Quantum Clinical Services Group | Philadelphia | Pennsylvania | 19139 | United States |
| Community Clinical Research | Austin | Texas | 78729 | United States |
| Future Search Trials | Austin | Texas | 78756 | United States |
| Claghorn-Lesem Research Clinic | Bellaire | Texas | 77401 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| CBH Health, L.L.C - Dominion Hospital | Falls Church | Virginia | 22044 | United States |
| 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. |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone 80 mg | 2 40 mg lurasidone tablets taken once/day |
| BG001 | Placebo | Matching placebo to lurasidone 40 mg tablets taken once/day |
| BG002 | 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 |
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| Sex: Female, Male | Count of Participants | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score | The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. | Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS. | Posted | Jan 2011 | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and 6 weeks |
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| Secondary | Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores | The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia. | Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS | Posted | Jan 2011 | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and 6 weeks |
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| Secondary | Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores | The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS. | Posted | Jan 2011 | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and 6 weeks |
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| Secondary | Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores | The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. | Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS. | Posted | Jan 2011 | Least Squares Mean | 95% Confidence Interval | units on scale | Baseline and 6 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 80 mg | 2 40 mg lurasidone tablets taken once/day | 2 | 90 | 53 | 90 | ||
| EG001 | Placebo | Matching placebo to lurasidone 40 mg tablets taken once/day | 3 | 90 | 37 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Creatine Phosphokinase Increased | Investigations |
| |||
| Schizophrenia NOS | Psychiatric disorders |
| |||
| Chronic Obstructive Airways Disease | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Toothache | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Akathisia | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Sedation | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Insomnia | Psychiatric disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josephine Cucchiaro, Executive Director | Sunovion | 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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