A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Study Details
Study Description
Brief Summary
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SM-13496 20-120mg once daily orally SM-13496 20-120 mg flexibly dosed |
Drug: SM-13496
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) [28, 52 weeks]
The number and percentage of subjects with at least one adverse event and adverse drug reaction
Secondary Outcome Measures
- Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score [Baseline, 52 weeks and each month]
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.
- Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. [Baseline, 52 weeks and each month]
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.
- Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. [Baseline to 52 weeks]
The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.
Eligibility Criteria
Criteria
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
-
Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.
-
Outpatients aged 18 through 74 years at the time of consent
-
Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but < 8 episodes in the previous 12 months prior to screening).
Exclusion Criteria:
-
Patients with imminent risk of suicide or injury to self, others, or property.
-
Patients who are otherwise considered ineligible for the study by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Japan 68 sites | Tokyo | Japan | ||
| 2 | Lithuania 3 sites | Kaunas | Lithuania | ||
| 3 | Malaysia 5 sites | Kuala Lumpur | Malaysia | ||
| 4 | Philippines 5 sites | Manila | Philippines | ||
| 5 | Russia 19 sites | Moscow | Russian Federation | ||
| 6 | Slovakia 5 sites | Zilina | Slovakia | ||
| 7 | Taiwan 8 sites | Taipei | Taiwan | ||
| 8 | Ukraine 9 sites | Kiev | Ukraine |
Sponsors and Collaborators
- Sumitomo Pharma Co., Ltd.
Investigators
- Study Director: Director, Drug Development Division, Sumitomo Pharma Co., Ltd.
Study Documents (Full-Text)
More Information
Publications
None provided.- D1002002
- JapicCTI-132319
- 2013-003039-31
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 495 represents the total number of subjects who were treated with study drug. |
| Arm/Group Title | SM-13496 20-120mg |
|---|---|
| Arm/Group Description | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg |
| Period Title: Overall Study | |
| STARTED | 495 |
| COMPLETED | 339 |
| NOT COMPLETED | 156 |
Baseline Characteristics
| Arm/Group Title | SM-13496 20-120mg |
|---|---|
| Arm/Group Description | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg |
| Overall Participants | 495 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
42.6
(12.78)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
259
52.3%
|
| Male |
236
47.7%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
225
45.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
270
54.5%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| Japan |
199
40.2%
|
| Philippines |
8
1.6%
|
| Taiwan |
7
1.4%
|
| Ukraine |
117
23.6%
|
| Malaysia |
11
2.2%
|
| Slovakia |
15
3%
|
| Lithuania |
9
1.8%
|
| Russia |
129
26.1%
|
Outcome Measures
| Title | Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) |
|---|---|
| Description | The number and percentage of subjects with at least one adverse event and adverse drug reaction |
| Time Frame | 28, 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) |
|---|---|---|
| Arm/Group Description | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks |
| Measure Participants | 495 | 199 |
| Count of Participants [Participants] |
352
71.1%
|
169
NaN
|
| Title | Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 52 weeks and each month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) |
|---|---|---|
| Arm/Group Description | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks |
| Measure Participants | 494 | 198 |
| Mean (Standard Deviation) [units on a scale] |
-4.4
(12.09)
|
1.1
(12.58)
|
| Title | Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 52 weeks and each month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) |
|---|---|---|
| Arm/Group Description | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks |
| Measure Participants | 494 | 198 |
| Mean (Standard Deviation) [units on a scale] |
-1.0
(4.54)
|
-2.0
(6.73)
|
| Title | Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. |
|---|---|
| Description | The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder. |
| Time Frame | Baseline to 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) |
|---|---|---|
| Arm/Group Description | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks |
| Measure Participants | 495 | 199 |
| Count of Participants [Participants] |
14
2.8%
|
18
NaN
|
Adverse Events
| Time Frame | Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) | ||
| Arm/Group Description | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks | once daily orally SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks | ||
All Cause Mortality |
||||
| SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/495 (0%) | 0/199 (0%) | ||
Serious Adverse Events |
||||
| SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/495 (3.8%) | 12/199 (6%) | ||
| General disorders | ||||
| Disease progression | 8/495 (1.6%) | 8 | 3/199 (1.5%) | 3 |
| Infections and infestations | ||||
| Urinary tract infection | 1/495 (0.2%) | 1 | 0/199 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Pelvic fracture | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Investigations | ||||
| Blood potassium decreased | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Glucose urine present | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Weight decreased | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 0/495 (0%) | 0 | 1/199 (0.5%) | 1 |
| Lactic acidosis | 0/495 (0%) | 0 | 1/199 (0.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Lumbar spinal stenosis | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Uterine cancer | 0/495 (0%) | 0 | 1/199 (0.5%) | 1 |
| Nervous system disorders | ||||
| Akathisia | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Psychomotor hyperactivity | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Psychiatric disorders | ||||
| Alcoholism | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Hallucination, auditory | 1/495 (0.2%) | 1 | 0/199 (0%) | 0 |
| Hallucination, visual | 1/495 (0.2%) | 1 | 0/199 (0%) | 0 |
| Mania | 1/495 (0.2%) | 1 | 1/199 (0.5%) | 1 |
| Suicidal ideation | 1/495 (0.2%) | 1 | 0/199 (0%) | 0 |
| Suicide attempt | 3/495 (0.6%) | 3 | 1/199 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| SM-13496 20-120mg (Overall, 28 Weeks) | SM-13496 20-120mg (Japan, 52 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 250/495 (50.5%) | 137/199 (68.8%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 14/495 (2.8%) | 15 | 10/199 (5%) | 11 |
| Nausea | 35/495 (7.1%) | 38 | 24/199 (12.1%) | 25 |
| Vomiting | 17/495 (3.4%) | 21 | 13/199 (6.5%) | 13 |
| General disorders | ||||
| Disease progression | 16/495 (3.2%) | 17 | 10/199 (5%) | 11 |
| Infections and infestations | ||||
| Nasopharyngitis | 51/495 (10.3%) | 63 | 53/199 (26.6%) | 72 |
| Investigations | ||||
| Weight increased | 31/495 (6.3%) | 31 | 17/199 (8.5%) | 17 |
| Nervous system disorders | ||||
| Akathisia | 91/495 (18.4%) | 104 | 60/199 (30.2%) | 64 |
| Dystonia | 13/495 (2.6%) | 15 | 10/199 (5%) | 11 |
| Headache | 37/495 (7.5%) | 46 | 16/199 (8%) | 19 |
| Parkinsonism | 34/495 (6.9%) | 43 | 15/199 (7.5%) | 25 |
| Somnolence | 41/495 (8.3%) | 44 | 24/199 (12.1%) | 24 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Research |
|---|---|
| Organization | Sumitomo Dainippon Pharmaceutical |
| Phone | +81-3-5159-2519 |
| cc@ds-pharma.co.jp |
- D1002002
- JapicCTI-132319
- 2013-003039-31