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Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

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: NCT00615433
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : February 14, 2011
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Lurasidone
Drug: Olanzapine
Drug: Placebo comparator
Drug: Lurasidone 40 mg tablets
Enrollment 478
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 40mg 120mg 15mg Olz Placebo
Hide Arm/Group Description Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication. 3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication. 3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication. Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
Period Title: Overall Study
Started 120 119 123 116
Completed 77 66 84 71
Not Completed 43 53 39 45
Arm/Group Title 40mg 120mg 15mg Olz Placebo Total
Hide Arm/Group Description Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication. 3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication. 3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication. Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated). Total of all reporting groups
Overall Number of Baseline Participants 119 118 122 116 475
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 118 participants 122 participants 116 participants 475 participants
37.7  (11.0) 37.9  (11.2) 38.3  (10.2) 36.9  (11.3) 37.7  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 118 participants 122 participants 116 participants 475 participants
Female
26
  21.8%
25
  21.2%
27
  22.1%
26
  22.4%
104
  21.9%
Male
93
  78.2%
93
  78.8%
95
  77.9%
90
  77.6%
371
  78.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 118 participants 122 participants 116 participants 475 participants
United States 70 72 74 68 284
Philippines 7 6 8 5 26
Lithuania 7 7 7 8 29
Colombia 12 12 12 12 48
India 23 21 21 23 88
1.Primary Outcome
Title Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
Hide Description The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.
Arm/Group Title 40mg 120mg 15mg Olz Placebo
Hide Arm/Group Description:
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
3 40 mg tablets taken orally once a day.
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
Overall Number of Participants Analyzed 118 118 121 114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-25.7
(-29.6 to -21.8)
-23.6
(-27.8 to -19.4)
-28.7
(-32.4 to -24.9)
-16.0
(-20.1 to -12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40mg, 120mg, Placebo
Comments Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni’s procedure for controlling pairwise differences.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
Hide Description The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.
Arm/Group Title 40mg 120mg 15mg Olz Placebo
Hide Arm/Group Description:
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
Overall Number of Participants Analyzed 119 118 122 114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: scale
-1.5
(-1.7 to -1.3)
-1.4
(-1.6 to -1.2)
-1.5
(-1.7 to -1.4)
-1.1
(-1.3 to -0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40mg, 120mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 40mg 120mg 15mg Olz Placebo
Hide Arm/Group Description Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication. 3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication. 3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication. Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
All-Cause Mortality
40mg 120mg 15mg Olz Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
40mg 120mg 15mg Olz Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/119 (1.68%)   6/118 (5.08%)   5/122 (4.10%)   5/116 (4.31%) 
Cardiac disorders         
Acute Myocardial Infarction  0/119 (0.00%)  0/118 (0.00%)  0/122 (0.00%)  1/116 (0.86%) 
Angina Pectoris  0/119 (0.00%)  0/118 (0.00%)  0/122 (0.00%)  1/116 (0.86%) 
Sinus Tachycardia  0/119 (0.00%)  0/118 (0.00%)  1/122 (0.82%)  0/116 (0.00%) 
Gastrointestinal disorders         
Heamatemesis  0/119 (0.00%)  0/118 (0.00%)  0/122 (0.00%)  1/116 (0.86%) 
Hepatobiliary disorders         
Hepatitis  0/119 (0.00%)  0/118 (0.00%)  1/122 (0.82%)  0/116 (0.00%) 
Infections and infestations         
Bronchopneumonia  0/119 (0.00%)  0/118 (0.00%)  1/122 (0.82%)  0/116 (0.00%) 
Psychiatric disorders         
Agitation  1/119 (0.84%)  0/118 (0.00%)  0/122 (0.00%)  1/116 (0.86%) 
Panic Attack  0/119 (0.00%)  0/118 (0.00%)  0/122 (0.00%)  1/116 (0.86%) 
Psychotic Disorder  0/119 (0.00%)  4/118 (3.39%)  1/122 (0.82%)  1/116 (0.86%) 
Schizophrenia  1/119 (0.84%)  2/118 (1.69%)  1/122 (0.82%)  0/116 (0.00%) 
Substance Abuse  1/119 (0.84%)  0/118 (0.00%)  0/122 (0.00%)  0/116 (0.00%) 
Suicidal Ideation  1/119 (0.84%)  1/118 (0.85%)  1/122 (0.82%)  0/116 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
40mg 120mg 15mg Olz Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   90/119 (75.63%)   96/118 (81.36%)   98/122 (80.33%)   84/116 (72.41%) 
Gastrointestinal disorders         
Constipation  6/119 (5.04%)  9/118 (7.63%)  8/122 (6.56%)  6/116 (5.17%) 
Dry Mouth  2/119 (1.68%)  3/118 (2.54%)  12/122 (9.84%)  1/116 (0.86%) 
Dyspepsia  9/119 (7.56%)  9/118 (7.63%)  5/122 (4.10%)  7/116 (6.03%) 
Nausea  13/119 (10.92%)  9/118 (7.63%)  6/122 (4.92%)  5/116 (4.31%) 
Salivary Hypersecretion  2/119 (1.68%)  8/118 (6.78%)  1/122 (0.82%)  0/116 (0.00%) 
Tootache  4/119 (3.36%)  3/118 (2.54%)  12/122 (9.84%)  6/116 (5.17%) 
Vomiting  5/119 (4.20%)  10/118 (8.47%)  2/122 (1.64%)  8/116 (6.90%) 
Investigations         
Weight Increased  2/119 (1.68%)  2/118 (1.69%)  25/122 (20.49%)  6/116 (5.17%) 
Metabolism and nutrition disorders         
Decreased Appetite  6/119 (5.04%)  1/118 (0.85%)  2/122 (1.64%)  2/116 (1.72%) 
Increased Appetite  1/119 (0.84%)  3/118 (2.54%)  7/122 (5.74%)  4/116 (3.45%) 
Musculoskeletal and connective tissue disorders         
Back Pain  6/119 (5.04%)  6/118 (5.08%)  7/122 (5.74%)  4/116 (3.45%) 
Musculoskeletal Stiffness  3/119 (2.52%)  6/118 (5.08%)  3/122 (2.46%)  2/116 (1.72%) 
Nervous system disorders         
Akathisia  14/119 (11.76%)  27/118 (22.88%)  9/122 (7.38%)  1/116 (0.86%) 
Dizziness  5/119 (4.20%)  6/118 (5.08%)  3/122 (2.46%)  2/116 (1.72%) 
Dystonia  4/119 (3.36%)  9/118 (7.63%)  1/122 (0.82%)  1/116 (0.86%) 
Headache  26/119 (21.85%)  21/118 (17.80%)  17/122 (13.93%)  25/116 (21.55%) 
Parkinsonism  11/119 (9.24%)  13/118 (11.02%)  6/122 (4.92%)  2/116 (1.72%) 
Sedation  11/119 (9.24%)  16/118 (13.56%)  17/122 (13.93%)  4/116 (3.45%) 
Somnolence  11/119 (9.24%)  18/118 (15.25%)  11/122 (9.02%)  5/116 (4.31%) 
Tremor  2/119 (1.68%)  9/118 (7.63%)  7/122 (5.74%)  5/116 (4.31%) 
Psychiatric disorders         
Agitation  13/119 (10.92%)  7/118 (5.93%)  8/122 (6.56%)  6/116 (5.17%) 
Anxiety  12/119 (10.08%)  12/118 (10.17%)  7/122 (5.74%)  8/116 (6.90%) 
Insomnia  15/119 (12.61%)  14/118 (11.86%)  13/122 (10.66%)  13/116 (11.21%) 
Psychotic Disorder  2/119 (1.68%)  0/118 (0.00%)  3/122 (2.46%)  7/116 (6.03%) 
Restlessness  6/119 (5.04%)  4/118 (3.39%)  4/122 (3.28%)  3/116 (2.59%) 
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.
For multi-center studies, it is mandatory that the first publication is based on all data obtained from all analyses as stipulated in the protocol. Investigators participating in multicenter studies must agree not to present data gathered individually or by subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and also by Sunovion.
Results Point of Contact
Name/Title: Josephine Cucchiaro, Executive Director
Organization: Sunovion Pharmacetuicals Inc.
Phone: 201-592-2050
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00615433     History of Changes
Other Study ID Numbers: D1050231
First Submitted: February 1, 2008
First Posted: February 14, 2008
Results First Submitted: November 8, 2010
Results First Posted: February 14, 2011
Last Update Posted: June 12, 2015