Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

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: NCT00868959
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : April 1, 2014
Last Update Posted : April 14, 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 Depression
Intervention Drug: lurasidone
Enrollment 817
Recruitment Details  
Pre-assignment Details 817 represents the total number of subjects who provided informed consent and enrolled, which is different from the total number of subjects who were treated with study drug, which was 813.
Arm/Group Title Lurasidone
Hide Arm/Group Description lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Period Title: Overall Study
Started 817 [1]
Completed 559
Not Completed 258
[1]
817 represents total number of subjects who provided informed consent.
Arm/Group Title Lurasidone
Hide Arm/Group Description lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Overall Number of Baseline Participants 813
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 813 participants
42.7  (12.03)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 813 participants
<=18 years
6
   0.7%
Between 18 and 65 years
790
  97.2%
>=65 years
17
   2.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 813 participants
Female
427
  52.5%
Male
386
  47.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 813 participants
United States 283
Slovakia 19
Ukraine 78
Lithuania 16
Russian Federation 31
Colombia 15
India 128
France 23
Czech Republic 108
Canada 14
Poland 12
Romania 9
Peru 12
South Africa 56
Japan 6
Germany 3
1.Primary Outcome
Title Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment
Hide Description Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurasidone
Hide Arm/Group Description:
lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Overall Number of Participants Analyzed 813
Measure Type: Number
Unit of Measure: participants
529
2.Secondary Outcome
Title Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a clinician-rated assessment of the subject’s level of depression. Ten items are rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurasidone
Hide Arm/Group Description:
lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Overall Number of Participants Analyzed 813
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.4  (10.60)
3.Secondary Outcome
Title Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Hide Description This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurasidone
Hide Arm/Group Description:
lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Overall Number of Participants Analyzed 813
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.58  (1.325)
Time Frame 24 Weeks
Adverse Event Reporting Description January 22, 2009 - February 19, 2013 - recruitment period
 
Arm/Group Title Lurasidone
Hide Arm/Group Description lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
All-Cause Mortality
Lurasidone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lurasidone
Affected / at Risk (%) # Events
Total   24/813 (2.95%)    
Gastrointestinal disorders   
Pancreatitis  1  1/813 (0.12%)  1
General disorders   
Disease Progression  1  1/813 (0.12%)  1
Immune system disorders   
Hypersensitivity  1  1/813 (0.12%)  1
Infections and infestations   
Appendicitis  1  1/813 (0.12%)  1
Injury, poisoning and procedural complications   
Hand Fracture  1  1/813 (0.12%)  1
Humerous Fracture  1  1/813 (0.12%)  1
Radius Fracture  1  1/813 (0.12%)  1
Road Traffic Accident  1  1/813 (0.12%)  1
Musculoskeletal and connective tissue disorders   
Lumbar Spinal Stenosis  1  1/813 (0.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lip Neoplasm Malignant Stage Unspecified  1  1/813 (0.12%)  1
Psychiatric disorders   
Completed Suicide  1  1/813 (0.12%)  1
Depression  1  6/813 (0.74%)  6
Depression Suicidal  1  2/813 (0.25%)  2
Major Depression  1  1/813 (0.12%)  1
Mania  1  2/813 (0.25%)  2
Suicidal Ideation  1  1/813 (0.12%)  1
Suicide Attempt  1  2/813 (0.25%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lurasidone
Affected / at Risk (%) # Events
Total   246/813 (30.26%)    
Gastrointestinal disorders   
Nausea  1  62/813 (7.63%)  90
Nervous system disorders   
Akathisia  1  66/813 (8.12%)  84
Headache  1  63/813 (7.75%)  76
Parkinsonism  1  43/813 (5.29%)  54
Psychiatric disorders   
Anxiety  1  47/813 (5.78%)  56
Insomnia  1  52/813 (6.40%)  60
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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 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 following completion of study at all sites, the PI shall be free to publish.
Results Point of Contact
Name/Title: Medical Director, CNS
Organization: Sunovion
Phone: 1-866-503-6351
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00868959     History of Changes
Other Study ID Numbers: D1050256
EUDRACT No. 2008-007483-42
First Submitted: March 23, 2009
First Posted: March 25, 2009
Results First Submitted: February 17, 2014
Results First Posted: April 1, 2014
Last Update Posted: April 14, 2016