Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986114
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : July 23, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar I Disorder
Intervention Drug: SM-13496
Enrollment 495
Recruitment Details  
Pre-assignment Details 495 represents the total number of subjects who were treated with study drug.
Arm/Group Title SM-13496 20-120mg
Hide 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
Reason Not Completed
Adverse Event             59
Lack of Efficacy             23
Withdrawal by Subject             58
Noncompliance             3
Protocol Violation             1
Lost to Follow-up             5
Other reason             7
Arm/Group Title SM-13496 20-120mg
Hide Arm/Group Description

once daily orally

SM-13496 (lurasidone HCl): SM-13496 20-120mg

Overall Number of Baseline Participants 495
Hide Baseline Analysis Population Description
Safety population-received at least one dose of study medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 495 participants
42.6  (12.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 495 participants
Female
259
  52.3%
Male
236
  47.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 495 participants
American Indian or Alaska Native
0
   0.0%
Asian
225
  45.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
270
  54.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 495 participants
Japan 199
Philippines 8
Taiwan 7
Ukraine 117
Malaysia 11
Slovakia 15
Lithuania 9
Russia 129
1.Primary Outcome
Title Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
Hide Description The number and percentage of subjects with at least one adverse event and adverse drug reaction
Time Frame 28, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SM-13496 20-120mg (Overall, 28 Weeks) SM-13496 20-120mg (Japan, 52 Weeks)
Hide 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

Overall Number of Participants Analyzed 495 199
Measure Type: Count of Participants
Unit of Measure: Participants
352
  71.1%
169
  84.9%
2.Secondary Outcome
Title Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SM-13496 20-120mg (Overall, 28 Weeks) SM-13496 20-120mg (Japan, 52 Weeks)
Hide 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

Overall Number of Participants Analyzed 494 198
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.4  (12.09) 1.1  (12.58)
3.Secondary Outcome
Title Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SM-13496 20-120mg (Overall, 28 Weeks) SM-13496 20-120mg (Japan, 52 Weeks)
Hide 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

Overall Number of Participants Analyzed 494 198
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (4.54) -2.0  (6.73)
4.Secondary Outcome
Title Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SM-13496 20-120mg (Overall, 28 Weeks) SM-13496 20-120mg (Japan, 52 Weeks)
Hide 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

Overall Number of Participants Analyzed 495 199
Measure Type: Count of Participants
Unit of Measure: Participants
14
   2.8%
18
   9.0%
Time Frame Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SM-13496 20-120mg (Overall, 28 Weeks) SM-13496 20-120mg (Japan, 52 Weeks)
Hide 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 (%) Affected / at Risk (%)
Total   0/495 (0.00%)      0/199 (0.00%)    
Hide 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 (3.84%)      12/199 (6.03%)    
General disorders     
Disease progression  1  8/495 (1.62%)  8 3/199 (1.51%)  3
Infections and infestations     
Urinary tract infection  1  1/495 (0.20%)  1 0/199 (0.00%)  0
Injury, poisoning and procedural complications     
Pelvic fracture  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Investigations     
Blood potassium decreased  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Glucose urine present  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Weight decreased  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/495 (0.00%)  0 1/199 (0.50%)  1
Lactic acidosis  1  0/495 (0.00%)  0 1/199 (0.50%)  1
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine cancer  1  0/495 (0.00%)  0 1/199 (0.50%)  1
Nervous system disorders     
Akathisia  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Psychomotor hyperactivity  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Psychiatric disorders     
Alcoholism  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Hallucination, auditory  1  1/495 (0.20%)  1 0/199 (0.00%)  0
Hallucination, visual  1  1/495 (0.20%)  1 0/199 (0.00%)  0
Mania  1  1/495 (0.20%)  1 1/199 (0.50%)  1
Suicidal ideation  1  1/495 (0.20%)  1 0/199 (0.00%)  0
Suicide attempt  1  3/495 (0.61%)  3 1/199 (0.50%)  1
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (50.51%)      137/199 (68.84%)    
Gastrointestinal disorders     
Diarrhoea  1  14/495 (2.83%)  15 10/199 (5.03%)  11
Nausea  1  35/495 (7.07%)  38 24/199 (12.06%)  25
Vomiting  1  17/495 (3.43%)  21 13/199 (6.53%)  13
General disorders     
Disease progression  1  16/495 (3.23%)  17 10/199 (5.03%)  11
Infections and infestations     
Nasopharyngitis  1  51/495 (10.30%)  63 53/199 (26.63%)  72
Investigations     
Weight increased  1  31/495 (6.26%)  31 17/199 (8.54%)  17
Nervous system disorders     
Akathisia  1  91/495 (18.38%)  104 60/199 (30.15%)  64
Dystonia  1  13/495 (2.63%)  15 10/199 (5.03%)  11
Headache  1  37/495 (7.47%)  46 16/199 (8.04%)  19
Parkinsonism  1  34/495 (6.87%)  43 15/199 (7.54%)  25
Somnolence  1  41/495 (8.28%)  44 24/199 (12.06%)  24
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Clinical Research
Organization: Sumitomo Dainippon Pharmaceutical
Phone: +81-3-5159-2519
EMail: cc@ds-pharma.co.jp
Layout table for additonal information
Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01986114    
Other Study ID Numbers: D1002002
JapicCTI-132319 ( Registry Identifier: JAPIC Clinical Trials Information )
2013-003039-31 ( EudraCT Number )
First Submitted: November 4, 2013
First Posted: November 18, 2013
Results First Submitted: May 19, 2019
Results First Posted: July 23, 2019
Last Update Posted: August 13, 2019