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Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone | Experimental | Lurasidone 20, 40 or 60 mg |
|
| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | 20, 40, 60 mg, flexible dose, once daily PM 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores | The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score | The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. | Baseline to Week 6 |
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Inclusion Criteria:
Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
Subject is 18 to 75 years of age, inclusive.
Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).
Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):
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 Studies, Inc. | Birmingham | Alabama | 35226 | United States | ||
| Synergy Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30086213 | Derived | Clayton AH, Tsai J, Mao Y, Pikalov A, Loebel A. Effect of Lurasidone on Sexual Function in Major Depressive Disorder Patients With Subthreshold Hypomanic Symptoms (Mixed Features): Results From a Placebo-Controlled Trial. J Clin Psychiatry. 2018 Aug 7;79(5):18m12132. doi: 10.4088/JCP.18m12132. | |
| 29943445 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone | Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks |
| FG001 | Placebo | Placebo Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo |
|
| Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score | The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania. | Baseline to Week 6 |
| Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score | The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired). | Baseline to Week 6 |
| Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score | The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety. | Baseline to Week 6 |
| Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF). | Baseline to Week 6 |
| Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF) | Baseline to Week 6 |
| Escondido |
| California |
| 92025 |
| United States |
| Collaborative Neuroscience Network Inc. | Garden Grove | California | 92845 | United States |
| Stanford -VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
| Clinical Innovations Inc. | Riverside | California | 92506 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | United States |
| Florida Clinical Research Center, LLC | Sarasota | Florida | 34201 | United States |
| Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders | Boston | Massachusetts | 02114 | United States |
| St. Charles Psychiatric Associates/Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Social Psychiatric Research Inst. (SPRI) Clinical Trials | Brooklyn | New York | 11235 | United States |
| Village Clinical Research Inc. | New York | New York | 10003 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Behavioral Medical Research of Staten Island | Staten Island | New York | 10305 | United States |
| Psychiatry and Behavioral Sciences, Duke | Durham | North Carolina | 27705 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| CRI Worldwide - Kirkbride | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Dept. of Psychiatry, UT Southwestern Medical Center | Dallas | Texas | 75390-8849 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Saint Nicholas Psychiatric Hospital. | Saint Petersburg | 190121 | Russia |
| City Psychiatry Hospital 4 (Saint Petersburg Psychiatric Admitting Unit) | Saint Petersburg | 191119 | Russia |
| Federal State Institution "Saint-Petersburg Research psychoneurogical Institute named after V.M. Bekhtereva" | Saint Petersburg | 193167 | Russia |
| Municipal Healthcare Institution"City Clinical Hospital #2, n.a. V.I. Razumovsky" of Healthcare Committee of Administration of Municipal Entity "City of Saratov" | Saratov | 410028 | Russia |
| State Healthcare Institution, Saratov Regional Psychiatric Hospital of St.Sophia, | Saratov | 410060 | Russia |
| Limited Liability Company "Research-And-Educational Centre of Psychotherapy "Podderzhka" | Stavropol | 355000 | Russia |
| Institute of Mental Health | Belgrade | 11000 | Serbia |
| Psychiatric Clinic, Clinical Hospital Center"Dr. Dragisa Misovic-Dedinje" | Belgrade | 11000 | Serbia |
| Health Centre Cacak Department of Psychiatry | Čačak | 32000 | Serbia |
| Clinical Center Nis, Psychiatric Clinic | Gornja Toponica | 18201 | Serbia |
| Clinical Center Kragujevac, Psychiatric Clinic | Kragujevac | 34000 | Serbia |
| Clinic for Mental Health, Clinical Center Nis | Niš | 18000 | Serbia |
| Special Hospital for Psychiatric Diseases "Sveti Vracevi" | Vojvodina | 23330 | Serbia |
| Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic" | Vršac | 26300 | Serbia |
| General Hospital "Djordje Joanovic" Psychiatric Dept. | Zrenjanin | 23000 | Serbia |
| Dnipropetrovsk Regional Clinical Hospital named Mechnikov | Dnipropetrovsk | 49005 | Ukraine |
| State Institution "Institute of Neurology, Psychiatry and Narcology NAMS of Ukraine", Dep. of Clinical, Social and Child Psychiatry | Kharkiv | 61068 | Ukraine |
| Communal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association "Psychiatric Dept. #10 and Psychiatric Dept. #2 | Kyiv | 08631 | Ukraine |
| "Lugansk State Medical University"Chair of Psychiatry, Narcology and Medical Psychology; Lugansk Regional Clinical Psychoneurological Hospital, Dispensary Dept. for adults | Luhansk | 91045 | Ukraine |
| Municipal Institution "Lviv Regional State Clinical Psychiatric Hospital, Department #20 | Lviv | 79021 | Ukraine |
| Odesa Regional Psychoneurological Dispensary, Outpatient Dept. | Odesa | 65014 | Ukraine |
| Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept. of Psychiatry and Narcology, Vinnytsya Regional Psychoneurological Hospital n.a. O.I. Yushchenko, Dept. no. 14, Dept. no 15 | Vinnytsia | 21018 | Ukraine |
| MAC Clinical Research Limited | Cannock | WS11 0BN | United Kingdom |
| MAC Clinical Research Limited | Manchester | M32 0UT | United Kingdom |
| Targum SD, Pendergrass JC, Lee S, Loebel A. Ratings surveillance and reliability in a study of major depressive disorder with subthreshold hypomania (mixed features). Int J Methods Psychiatr Res. 2018 Dec;27(4):e1729. doi: 10.1002/mpr.1729. Epub 2018 Jun 26. |
| 26908089 | Derived | Targum SD, Suppes T, Pendergrass JC, Lee S, Silva R, Cucchiaro J, Loebel A. Major depressive disorder with subthreshold hypomania (mixed features): Clinical characteristics of patients entered in a multiregional, placebo-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jul 4;68:9-14. doi: 10.1016/j.pnpbp.2016.02.007. Epub 2016 Feb 22. |
| COMPLETED |
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| NOT COMPLETED |
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Two subjects were randomized in error and were not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone | Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks |
| BG001 | Placebo | Placebo Placebo: Placebo |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores | The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity. | Intent to treat population | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score | The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity. | Intent to treat population | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score | The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania. | Intent to treat population | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score | The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired). | Intent to treat population: If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score | The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety. | Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
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| Secondary | Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF). | Intent to treat population | Posted | Number | percentage of subjects | Baseline to Week 6 |
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| Secondary | Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF) | Intent to treat population | Posted | Number | percentage of subjects | Baseline to Week 6 |
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|
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 | Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks | 1 | 109 | 31 | 109 | ||
| EG001 | Placebo | Placebo Placebo: Placebo | 0 | 100 | 29 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression Suicidal | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Somnoelence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Haemarturia | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed.
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 post completion of study at all sites, PI shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 1-866-503-6351 | Sunovion | 1-866-503-6351 | clinicaltrialdisclosure@sunvion.com |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| 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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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Ukraine |
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| United Kingdom |
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| Serbia |
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