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This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296 (PERSISTExt)

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: NCT01575561
Recruitment Status : Completed
First Posted : April 11, 2012
Results First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar I Disorder
Intervention Drug: Lurasidone
Enrollment 377
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lurasidone
Hide Arm/Group Description

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Period Title: Overall Study
Started 377
Completed 338
Not Completed 39
Reason Not Completed
Adverse Event             9
Lack of Efficacy             8
Lost to Follow-up             6
Protocol Violation             4
Withdrawal by Subject             11
administration             1
Arm/Group Title Lurasidone
Hide Arm/Group Description

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Baseline Participants 377
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants
<=18 years
1
   0.3%
Between 18 and 65 years
359
  95.2%
>=65 years
17
   4.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 377 participants
45.5  (12.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants
Female
206
  54.6%
Male
171
  45.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants
Hispanic or Latino
62
  16.4%
Not Hispanic or Latino
315
  83.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 377 participants
American Indian or Alaska Native
1
   0.3%
Asian
15
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
28
   7.4%
White
327
  86.7%
More than one race
0
   0.0%
Unknown or Not Reported
6
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 377 participants
Czech Republic 40
Russian Federation 42
Argentina 30
Hungary 21
United States 95
Japan 13
Poland 37
Slovakia 5
Bulgaria 34
France 8
Chile 17
Serbia 35
1.Primary Outcome
Title Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events
Hide Description Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 377
Measure Type: Number
Unit of Measure: participants
at Least 1 TEAE potentially related to study drug 155
subjects with at least one TEAE potentially relate 69
at least 1 treatment emergent SAE 14
at least 1 treatment emergent SAE related to drug 1
at least 1 TEAE leading to discontinuation 9
2.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score
Hide Description The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.
Time Frame baseline, 12 weeks (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
only 351 of the 377 subjects had the QIDS-SR16 assessment at week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 351
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (3.23)
3.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score
Hide Description The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Time Frame baseline, 12 weeks (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
only 359 of the 377 subjects had the PANSS-P assessment at week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 359
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (1.16)
4.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)
Hide Description Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Time Frame Baseline, 12 weeks (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
only 375 of the 377 subjects had the YMRD assessment at week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (5.17)
5.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -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 of depression.
Time Frame baseline ,Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 375 of the 377 subjects had the MADRS assessment at week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.9  (6.82)
6.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)
Hide Description Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar 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.
Time Frame baseline, week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
only 375 of the 377 subjects had the CGI-BP-S overall assessment at week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
-.31  (1.068)
7.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score
Hide Description The CGI-BP-S mania score is a single value, clinician-rated assessment of mania 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
Time Frame baseline, week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 375 of the 377 subjects had the CGI-BP-S mania assessment at week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.13  (0.807)
8.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale
Hide Description The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.
Time Frame baseline, week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
only 375 of the 377 subjects had the CGI-BP-S depression assessment at Week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.27  (0.969)
9.Secondary Outcome
Title Change From Baseline to Week 12 (LOCF) in the SDS Total Score
Hide Description The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient’s life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. 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.
Time Frame baseline, week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
only 297 of the 377 subjects had the SDS total score at week 12 (LOCF)
Arm/Group Title Lurasidone
Hide Arm/Group Description:

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

Overall Number of Participants Analyzed 297
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.4  (5.98)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lurasidone
Hide Arm/Group Description

Lurasidone 20, 40, 60,80 mg flexible dose

Lurasidone: Lurasidone 20-80 mg taken orally once daily

All-Cause Mortality
Lurasidone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lurasidone
Affected / at Risk (%) # Events
Total   14/377 (3.71%)    
Blood and lymphatic system disorders   
anaemia megaloblastic * 1  1/377 (0.27%)  17
Injury, poisoning and procedural complications   
craniocerebral injury * 1  1/377 (0.27%)  1
femur fracture * 1  1/377 (0.27%)  1
intentional overdose * 1  1/377 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
basal cell carcinoma * 1  1/377 (0.27%)  1
Psychiatric disorders   
depression * 1  4/377 (1.06%)  4
mania * 1  2/377 (0.53%)  2
bipolar disorder * 1  1/377 (0.27%)  1
emotional distress * 1  1/377 (0.27%)  1
panic attack * 1  1/377 (0.27%)  1
persecutory delusion * 1  1/377 (0.27%)  1
accelerated hyertension * 1  1/377 (0.27%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Lurasidone
Affected / at Risk (%) # Events
Total   51/377 (13.53%)    
Gastrointestinal disorders   
nausea * 1  8/377 (2.12%)  9
Infections and infestations   
nasopharyngitis * 1  13/377 (3.45%)  14
Nervous system disorders   
headache * 1  15/377 (3.98%)  18
akathisia * 1  12/377 (3.18%)  13
Psychiatric disorders   
insomnia * 1  11/377 (2.92%)  12
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CNS Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
EMail: clinicaltrialdisclosure@sunvion.com
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01575561     History of Changes
Other Study ID Numbers: D1050308
2011-004789-14 ( EudraCT Number )
First Submitted: March 28, 2012
First Posted: April 11, 2012
Results First Submitted: July 11, 2016
Results First Posted: August 22, 2016
Last Update Posted: August 22, 2016