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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No. 2008-007457-13 |
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This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lurasidone low arm | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| lurasidone high arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lurasidone | Drug | lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. |
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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 |
|---|---|---|---|---|---|---|
| Synergy Escondido,710 East Grand Ave. | Escondido | California | 92025 | United States | ||
| Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24170180 | Result | Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984. | |
| 37339360 | Derived | Goldberg JF, Siu C, Tocco M, Pikalov A, Loebel A. The Effect of Lurasidone on Anxiety Symptoms in Patients With Bipolar Depression: A Post Hoc Analysis. J Clin Psychiatry. 2023 Jun 7;84(4):22m14732. doi: 10.4088/JCP.22m14732. |
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4/29/09 to 2/1/12
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo : Placebo Comparator |
| FG001 | Lurasidone High Arm | lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| lurasidone | Drug | lurasidone 20 mg/day for Days 1-7 |
|
| Placebo | Drug | Placebo Comparator |
|
| Baseline to Week 6 |
| Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score | Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items. | Baseline to Week 6 |
| Garden Grove |
| California |
| 92645 |
| United States |
| Excell Research, Inc,3998 Vista Way,Suite 100 | Oceanside | California | 92056 | United States |
| University of California at Irvine Medical Center | Orange | California | 92868 | United States |
| California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road | Pico Rivera | California | 90660 | United States |
| California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor | San Diego | California | 92102 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Florida Clinical Research Center, LLC,3914 State Road 64 East | Bradenton | Florida | 34208 | United States |
| Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230 | Maitland | Florida | 32751 | United States |
| Depression and Anxiety Disorders Research Institute | Tampa | Florida | 33613 | United States |
| Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103 | West Palm Beach | Florida | 33407 | United States |
| American Medical Research Inc.,1200 Harger Road Suite 415 | Oak Brook | Illinois | 60523 | United States |
| Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 | Lake Charles | Louisiana | 70601 | United States |
| Sheppard Pratt Health System,6501 North Charles Street | Baltimore | Maryland | 21285 | United States |
| Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209 | Albuquerque | New Mexico | 87109 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125 | Raleigh | North Carolina | 27609 | United States |
| Mood Disorders Program-UHCMC | Cleveland | Ohio | 44106 | United States |
| MetroHealth System | Cleveland | Ohio | 44122 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200 | Austin | Texas | 78756 | United States |
| Medical Services Prague s.r.o. | Kolejni 429-5 | Prague | Czechia |
| Psychiatricka ambulance | Brno - Mesto | 602 00 | Czechia |
| BIALBI s.r.o., Psychiatricke Oddeleni | Litoměřice | Czechia |
| Clintrial, s.r.o. | Prague | 10 100 00 | Czechia |
| Hopital Caremeau, Service de Psychiatrie A | Nîmes | 30 30029 | France |
| Zans Ritter, Marcel | Orvault | 44700 | France |
| S V Medical College | Tirupati | Andh Prad | 517507 | India |
| Vijayawada Institute of Mental Health and Neurosciences, Psychiatry | Vijaywada | Andh Prad | 520002 | India |
| Samvedna Hospitals | Ahmedabad | Gujarat | 380006 | India |
| Seth K M School of P G Medicine & Research | Ahmedabad | Gujarat | 380006 | India |
| Mental Illness Treatment Rehabilitationi Foundation | Ahmedabad | Gujarat | 380013 | India |
| Spandana Nursing Home | Bangalore | Karna | 560010 | India |
| Sujata Birla Hospital & Research Centre | Nashik | Mahara | 422101 | India |
| R.K. Yadav Memorial Mental Health & De-Addiction Hospital | Jaipur | Rajasthan | 302021 | India |
| Manobal Med. Research Centre | Lucknow | Uttar Prad | 226006 | India |
| Spitalul Clinic de Urgenta Militar Central | Bucdresti | 010825 | Romania |
| Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia | Bucharest | 041914 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj | Cluj-Napoca | 400012 | Romania |
| Spitalul Clinic de Neuropsihiatrie Craiova | Craiova | 200620 | Romania |
| Spitalul Clinic de Neurologie si Psihiatrie Oradea | Oradea | 410154 | Romania |
| City Psychiatric Hospital #2 of St. Nikolay Chudotvorets | Saint Petersburg | 190121 | Russia |
| Bekhterev Scientific Research Psychoneurological Institute | Saint Petersburg | 193019 | Russia |
| Psychoneurology Dispensary #4 | Saint Petersburg | 197110 | Russia |
| Cape Trial Centre | Cape Town, W. Cape | 7530 | South Africa |
| Paarl Medical Centre | Paarl, W. Cape | 7646 | South Africa |
| Clinika | Port Elizabeth, E. Cape | 6000 | South Africa |
| Dey Clinic | Pretoria, Gauteng | 0181 | South Africa |
| Vereeniging Medi-Clinic | Vereeniging, Free State | 1941 | South Africa |
| Chair of Psychiatry and Medical Psychology | Donetsk | Donetsk Oblast | 83008 | Ukraine |
| Reg. Psychiatric Hospital | Odesa | Ukraine |
| Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B | Poltava | 36006 | Ukraine |
| CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I | Simferopol | 95006 | Ukraine |
| Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21 | Vinnitsia | 21018 | Ukraine |
| 30102967 | Derived | Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10. |
| 27529375 | Derived | Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261. |
| 27215976 | Derived | Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y. |
| 26730454 | Derived | Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22. |
| 26363720 | Derived | Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5. |
| 25844756 | Derived | McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410. |
| FG002 | Lurasidone Low Arm | lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day |
| Intent-to-Treat Population |
|
| Safety Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
Intent-to-treat population is analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo : Placebo Comparator |
| BG001 | Lurasidone High Arm | lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day |
| BG002 | Lurasidone Low Arm | lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day |
| 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 | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. | Intent-to-treat population is analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
|
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| Secondary | Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. | Intent-to-treat population is analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score | Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items. | Intent-to-treat population is analyzed. Number of participants in table is not consistent with intent-to-treat population because: if one or more items are missing at a study visit, as can occur when a subject opts out of the work/school item because it does not apply, the authors of the scale recommend setting the total score to missing | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
|
April 29,2009 - February 1, 2012
Safety population is analyzed.
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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 | Placebo | Placebo : Placebo Comparator | 1 | 168 | 56 | 168 | ||
| EG001 | Lurasidone High Arm | lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day | 5 | 167 | 65 | 167 | ||
| EG002 | Lurasidone Low Arm | lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day | 3 | 164 | 57 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Panic Attack | Psychiatric disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MeDRA 14.1 | Systematic Assessment |
| |
| Restless Leg Syndrome | Injury, poisoning and procedural complications | MeDRA 14.1 | Systematic Assessment |
| |
| HIV Infection | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Subcutaneous Absceses | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MeDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MeDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
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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 | 1-866-503-6351 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| 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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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| United States |
|
| Czech Republic |
|
| Ukraine |
|
| Romania |
|
| South Africa |
|
| Russian Federation |
|
| India |
|
| Mixed Models Analysis |
| <0.001 |
| Mean Difference (Final Values) |
| -4.6 |
| Standard Error of the Mean |
| 1.17 |
A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group. |
| No |
| Superiority or Other |
|
|
|
| Lurasidone Low Arm |
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day |
|
|
|