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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No. 2008-007482-23 |
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This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lurasidone + (lithium or divalproex) | Drug | lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) | MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Baseline, 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) | CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. |
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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 |
|---|---|---|---|---|---|---|
| Woodland International Research Inc. | Little Rock | Arkansas | 72211 | United States | ||
| South Coast Clinical Trials, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24170221 | Result | Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985. | |
| 38639433 | Derived |
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5/11/2009 - 1/9/2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone | lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. |
| FG001 | Placebo | Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo + (lithium or divalproex) | Drug | 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7 |
|
| Baseline Week 6 |
| Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score | STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Baselin Week 6 |
| Anaheim |
| California |
| 92804 |
| United States |
| Catalina Research Institute | Chino | California | 91710 | United States |
| Synergy Escondido | Escondido | California | 92025 | United States |
| Collaborative Neuroscience Network Inc.,12772 Valley View Street | Garden Grove | California | 92645 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California at Irvine Medical Center | Orange | California | 92868 | United States |
| CNRI - Los Angeles LLC,8309 Telegraph Road | Pico Rivera | California | 90660 | United States |
| CNRI - San Diego, LLC | San Diego | California | 92102 | United States |
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Depression and Anxiety Disorders Research Institue | Tampa | Florida | 33613 | United States |
| American Medical Research Inc.,1200 Harger Road Suite 415 | Oak Brook | Illinois | 60523 | United States |
| American Medical Research, Inc., 1200 Harger Road Suite 415 | Oak Brook | Illinois | 60523 | United States |
| J. Gary Booker, MD | Shreveport | Louisiana | 71104 | United States |
| Sheppard Pratt Health System,6501 North Charles Street | Baltimore | Maryland | 21285 | United States |
| Capital Clinical Research,5515 Security Lane, Suite 525 | Rockville | Maryland | 20852 | United States |
| Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209 | Albuquerque | New Mexico | 87109 | United States |
| Lake Charles Clinical Trials LLC,700 Spring Forest Road | Raleigh | North Carolina | 27609 | United States |
| Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125 | Raleigh | North Carolina | 27609 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Mood Disorders Program-UHCMC | Cleveland | Ohio | 44106 | United States |
| MetroHealth System | Cleveland | Ohio | 44122 | United States |
| Midwest Clinical research Center, One Elizabeth Place, Suite G-3 | Dayton | Ohio | 45408 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200 | Austin | Texas | 78756 | United States |
| Psychiatricka ambulance | Brno - Mesto | 602 00 | Czechia |
| BIALBI s.r.o. Psychiatricke oddeleni | Litoměřice | 412 01 | Czechia |
| Clintrial, s.r.o. | Prague | 10 100 00 | Czechia |
| Medical Services Prague s.r.o. | Prague | 6 160 00 | Czechia |
| Psychiatricka ambulance Prosek | Prague | 9 190 00 | Czechia |
| Hopital Caremeau, Service de Psychiatrie A | Nîmes | 30 30029 | France |
| Zans Ritter, Marcel | Orvault | 44700 | France |
| Jana Thomsen | Berlin BE | 10245 | Germany |
| SV 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 |
| Sheth Vadilal Sarabhai General Hospital | Ahmedabad | Gujarat | 380006 | India |
| Mental Illness Treatment Rehabilitation Foundation (MITR) | Ahmedabad | Gujarat | 380013 | India |
| Shree Hatkesh Health Foundation | Jūnāgadh | Gujarat | 362001 | India |
| Spandana Nursing Home | Bangalore | Karna | 560010 | India |
| Sujata Birla Hospital & Research Centre | Nashik | Mahara | 422101 | India |
| Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry | Delhi | National Capital Territory of Delhi | 110092 | India |
| R.K. Yadav Memorial Mental Health & De-Addiction Hospital | Jaipur | Rajasthan | 302021 | India |
| Manobal Med. Research Centre | Lucknow | Uttar Prad | 226006 | India |
| ZOZ Poradnia Zdrowia Psychicznego | Chełmno | 86-200 | Poland |
| Praktyka Lekarska Sensorium S.M.O. | Skorzewo | 60-185 | Poland |
| Wojewodzki Szpital Brodnowski SP ZOZ | Warsaw | 03-242 | Poland |
| Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie | Bucharest | 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 |
| Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric | Piteşti | 110069 | Romania |
| Russian State Medical University | Moscow | 117997 | Russia |
| Moscow Medical Academy named I.M. Sechenov | Moscow | 119435 | Russia |
| 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 |
| LLC International Medical Centre "SOGAZ" | Saint Petersburg | 198035 | 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 |
| Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy | Donetsk | 83008 | Ukraine |
| Odesa Regional Psychoneurological Dispensary | Odesa | 65014 | Ukraine |
| Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM | Poltava | 36006 | Ukraine |
| CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1 | Simferopol | 95006 | Ukraine |
| Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog | Vinnitsia | 21005 | Ukraine |
| Tocco M, Mao Y. Efficacy and Safety of Adding Lurasidone to Ongoing Therapy With Lithium or Valproate for the Treatment of an Acute Bipolar Depressive Episode: A Post Hoc Analysis of 2 Placebo-Controlled Trials. J Clin Psychopharmacol. 2024 Jul-Aug 01;44(4):345-352. doi: 10.1097/JCP.0000000000001850. Epub 2024 Apr 19. |
| 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. |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Data for full analysis set is provided (intent-to-treat population)
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone | lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. |
| BG001 | Placebo | Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7 |
| BG002 | 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 | Data for full analysis set is provided. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Data for full analysis set is provided. | 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) | MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Full analysis set (intent-to-treat population) | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Full analyis set (intent-to-treat population) | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline Week 6 |
|
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| Secondary | Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score | STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Full analysis set (intent-to-treat population) | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baselin Week 6 |
|
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Adverse event reporting begins at time of informed consent signature and continues until patient discontinuatiion - 6 Weeks
Number of participants at risk is the Safety Analysis Set (all randomized subjects exposed to at least one dose of study medicaton).
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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 | lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. | 2 | 183 | 73 | 183 | ||
| EG001 | Placebo | Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7 | 2 | 163 | 51 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (14.1) | 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 | 1-866-503-6351 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| D008094 | Lithium |
| D014635 | Valproic Acid |
| 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 |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| >=65 years |
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| Male |
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| United States |
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| Czech Republic |
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| Poland |
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| Ukraine |
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| Romania |
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| South Africa |
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| Russian Federation |
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| Germany |
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| India |
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