Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132319 | Registry Identifier | JAPIC Clinical Trials Information | |
| 2013-003039-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SM-13496 20-120mg | Experimental | once daily orally SM-13496 20-120 mg flexibly dosed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SM-13496 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | The number and percentage of subjects with at least one adverse event and adverse drug reaction | 28, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | 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. |
Not provided
Inclusion Criteria:
Patients who completed the D1002001 study
・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.
Patients who did not participate in the D1002001 study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Director, Drug Development Division | Sumitomo Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan 68 sites | Tokyo | Japan | ||||
| Lithuania 3 sites |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34342746 | Derived | Higuchi T, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Ishigooka J. Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study. Int J Bipolar Disord. 2021 Aug 2;9(1):25. doi: 10.1186/s40345-021-00230-8. | |
| 33321381 | Derived | Ishigooka J, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Higuchi T. Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study. J Affect Disord. 2021 Feb 15;281:160-167. doi: 10.1016/j.jad.2020.12.005. Epub 2020 Dec 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
495 represents the total number of subjects who were treated with study drug.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SM-13496 20-120mg | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population-received at least one dose of study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SM-13496 20-120mg | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) | The number and percentage of subjects with at least one adverse event and adverse drug reaction | Posted | Count of Participants | Participants | 28, 52 weeks |
|
Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SM-13496 20-120mg (Overall, 28 Weeks) | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research | Sumitomo Dainippon Pharmaceutical | +81-3-5159-2519 | cc@ds-pharma.co.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2016 | May 16, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2018 | May 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 52 weeks and each month |
| Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS 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 YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items. | Baseline, 52 weeks and each month |
| Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder. | Baseline to 52 weeks |
| Kaunas |
| Lithuania |
| Malaysia 5 sites | Kuala Lumpur | Malaysia |
| Philippines 5 sites | Manila | Philippines |
| Russia 19 sites | Moscow | Russia |
| Slovakia 5 sites | Žilina | Slovakia |
| Taiwan 8 sites | Taipei | Taiwan |
| Ukraine 9 sites | Kiev | Ukraine |
| Noncompliance |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Other reason |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 52 weeks and each month |
|
|
|
| Secondary | Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. | YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS 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 YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 52 weeks and each month |
|
|
|
| Secondary | Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. | The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder. | Posted | Count of Participants | Participants | Baseline to 52 weeks |
|
|
|
| 0 |
| 495 |
| 19 |
| 495 |
| 250 |
| 495 |
| EG001 | SM-13496 20-120mg (Japan, 52 Weeks) | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks | 0 | 199 | 12 | 199 | 137 | 199 |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
Not provided
Not provided
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |