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A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00044044
Recruitment Status : Completed
First Posted : August 20, 2002
Results First Posted : April 12, 2011
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Lurasidone 20 mg
Drug: Lurasidone 40mg
Drug: Lurasidone 80 mg
Drug: Haloperidol 10mg
Drug: Placebo
Enrollment 356
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Hide Arm/Group Description Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group. Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group. Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group. 10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group. Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.
Period Title: Overall Study
Started 71 69 71 73 72
Completed 27 28 31 29 36
Not Completed 44 41 40 44 36
Arm/Group Title 20 mg 40 mg 80 mg 10 mg Haloperidol Placebo Total
Hide Arm/Group Description Lurasidone 20 mg oral tablet taken once a day Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication. Lurasidone 80 mg oral tablet taken once a day 10 mg Haloperidol overencapsulated 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 (356). The number of subjects in the baseline characteristics is based on the safety population (353). 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 10 mg haloperidol treatment group did not take any study medication. Oral Capsule matching treatment group taken oce a day Total of all reporting groups
Overall Number of Baseline Participants 71 67 71 72 72 353
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 67 participants 71 participants 72 participants 72 participants 353 participants
40.7  (10.5) 42.0  (10.9) 42.2  (8.3) 40.0  (10.5) 41.0  (9.7) 41.2  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 67 participants 71 participants 72 participants 72 participants 353 participants
Female
20
  28.2%
21
  31.3%
19
  26.8%
14
  19.4%
17
  23.6%
91
  25.8%
Male
51
  71.8%
46
  68.7%
52
  73.2%
58
  80.6%
55
  76.4%
262
  74.2%
1.Primary Outcome
Title Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
Hide Description The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Arm/Group Title 20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Hide Arm/Group Description:
Lurasidone 20 mg oral tablet taken once a day
Lurasidone 40 mg oral tablet taken once a day
Lurasidone 80 mg oral tablet taken once a day
10 mg Haloperidol overencapsulated tablet taken orally once a day
Oral Capsule matching treatment group taken oce a day
Overall Number of Participants Analyzed 71 65 70 72 71
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.0  (1.38) -5.2  (1.44) -8.0  (1.40) -9.8  (1.37) -7.9  (1.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg, 40 mg, 80 mg, 10 mg Haloperidol, 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 ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
Hide Description The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Arm/Group Title 20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Hide Arm/Group Description:
Lurasidone 20 mg oral tablet taken once a day
Lurasidone 40 mg oral tablet taken once a day
Lurasidone 80 mg oral tablet taken once a day
10 mg Haloperidol overencapsulated tablet taken orally once a day
Oral Capsule matching treatment group taken oce a day
Overall Number of Participants Analyzed 71 65 70 72 71
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.1  (2.31) -7.2  (2.42) -13.6  (2.34) -16.0  (2.29) -12.3  (2.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg, 40 mg, 80 mg, 10 mg Haloperidol, 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 ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
Hide Description The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Arm/Group Title 20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Hide Arm/Group Description:
Lurasidone 20 mg oral tablet taken once a day
Lurasidone 40 mg oral tablet taken once a day
Lurasidone 80 mg oral tablet taken once a day
10 mg Haloperidol overencapsulated tablet taken orally once a day
Oral Capsule matching treatment group taken oce a day
Overall Number of Participants Analyzed 71 64 70 71 71
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.5  (0.11) -0.4  (0.12) -0.8  (0.12) -0.8  (0.12) -0.7  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg, 40 mg, 80 mg, 10 mg Haloperidol, 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 ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
Hide Description The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Arm/Group Title 20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Hide Arm/Group Description:
Lurasidone 20 mg oral tablet taken once a day
Lurasidone 40 mg oral tablet taken once a day
Lurasidone 80 mg oral tablet taken once a day
10 mg Haloperidol overencapsulated tablet taken orally once a day
Oral Capsule matching treatment group taken oce a day
Overall Number of Participants Analyzed 71 64 70 72 71
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
-1.3  (0.97) -1.1  (1.02) -2.5  (0.98) -2.7  (0.96) -1.9  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg, 40 mg, 80 mg, 10 mg Haloperidol, 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 ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Hide Arm/Group Description Lurasidone 20 mg oral tablet taken once a day Lurasidone 40 mg oral tablet taken once a day Lurasidone 80 mg oral tablet taken once a day 10 mg Haloperidol overencapsulated tablet taken orally once a day Oral Capsule matching treatment group taken oce a day
All-Cause Mortality
20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/71 (5.63%)      9/67 (13.43%)      3/71 (4.23%)      5/72 (6.94%)      7/72 (9.72%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Uterine Leiomyoma  1/71 (1.41%)  1 0/67 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/72 (0.00%)  0
Nervous system disorders           
Grand Mal Convulsion  0/71 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/72 (1.39%)  1
Psychiatric disorders           
Abnormal Behavior  0/71 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/72 (0.00%)  0
Agitation  0/71 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/72 (1.39%)  1
Anxiety  0/71 (0.00%)  0 0/67 (0.00%)  0 1/71 (1.41%)  1 1/72 (1.39%)  1 0/72 (0.00%)  0
Schizophrenia  2/71 (2.82%)  2 8/67 (11.94%)  8 2/71 (2.82%)  2 3/72 (4.17%)  3 4/72 (5.56%)  4
Suicidal Ideation  1/71 (1.41%)  1 1/67 (1.49%)  1 0/71 (0.00%)  0 2/72 (2.78%)  2 1/72 (1.39%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
20 mg 40 mg 80 mg 10 mg Haloperidol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/71 (69.01%)      51/67 (76.12%)      51/71 (71.83%)      58/72 (80.56%)      50/72 (69.44%)    
Gastrointestinal disorders           
Abdominal Discomfort  1/71 (1.41%)  1 0/67 (0.00%)  0 0/71 (0.00%)  0 5/72 (6.94%)  5 1/72 (1.39%)  1
Constipation  2/71 (2.82%)  2 1/67 (1.49%)  1 6/71 (8.45%)  6 3/72 (4.17%)  3 9/72 (12.50%)  9
Diarrhea  3/71 (4.23%)  3 2/67 (2.99%)  2 2/71 (2.82%)  2 3/72 (4.17%)  3 5/72 (6.94%)  5
Dyspepsia  8/71 (11.27%)  8 6/67 (8.96%)  6 8/71 (11.27%)  8 5/72 (6.94%)  5 7/72 (9.72%)  7
Nausea  8/71 (11.27%)  8 7/67 (10.45%)  7 13/71 (18.31%)  13 4/72 (5.56%)  4 8/72 (11.11%)  8
Toothache  2/71 (2.82%)  2 1/67 (1.49%)  1 1/71 (1.41%)  1 1/72 (1.39%)  1 4/72 (5.56%)  4
Vomiting  5/71 (7.04%)  5 5/67 (7.46%)  5 12/71 (16.90%)  12 4/72 (5.56%)  4 5/72 (6.94%)  5
General disorders           
Fatigue  5/71 (7.04%)  5 2/67 (2.99%)  2 9/71 (12.68%)  9 7/72 (9.72%)  7 3/72 (4.17%)  3
Pain  1/71 (1.41%)  1 4/67 (5.97%)  4 2/71 (2.82%)  2 1/72 (1.39%)  1 5/72 (6.94%)  5
Infections and infestations           
Nasopharyngitis  3/71 (4.23%)  3 2/67 (2.99%)  2 1/71 (1.41%)  1 4/72 (5.56%)  4 2/72 (2.78%)  2
Musculoskeletal and connective tissue disorders           
Back Pain  0/71 (0.00%)  0 4/67 (5.97%)  4 2/71 (2.82%)  2 4/72 (5.56%)  4 1/72 (1.39%)  1
Musculoskeletal Stiffness  0/71 (0.00%)  0 4/67 (5.97%)  4 5/71 (7.04%)  5 4/72 (5.56%)  4 2/72 (2.78%)  2
Nervous system disorders           
Akathisia  4/71 (5.63%)  4 9/67 (13.43%)  9 13/71 (18.31%)  13 14/72 (19.44%)  14 7/72 (9.72%)  7
Dizziness  4/71 (5.63%)  4 3/67 (4.48%)  3 4/71 (5.63%)  4 3/72 (4.17%)  3 3/72 (4.17%)  3
Dystonia  0/71 (0.00%)  0 1/67 (1.49%)  1 2/71 (2.82%)  2 9/72 (12.50%)  9 1/72 (1.39%)  1
Extrapyramidal Disorder  3/71 (4.23%)  3 4/67 (5.97%)  4 4/71 (5.63%)  4 13/72 (18.06%)  13 3/72 (4.17%)  3
Headache  15/71 (21.13%)  15 16/67 (23.88%)  16 17/71 (23.94%)  17 14/72 (19.44%)  14 24/72 (33.33%)  24
Sedation  8/71 (11.27%)  8 11/67 (16.42%)  11 15/71 (21.13%)  15 15/72 (20.83%)  15 6/72 (8.33%)  6
Somnolence  3/71 (4.23%)  3 4/67 (5.97%)  4 7/71 (9.86%)  7 9/72 (12.50%)  9 4/72 (5.56%)  4
Tremor  1/71 (1.41%)  1 1/67 (1.49%)  1 0/71 (0.00%)  0 5/72 (6.94%)  5 1/72 (1.39%)  1
Psychiatric disorders           
Agitation  7/71 (9.86%)  7 9/67 (13.43%)  9 3/71 (4.23%)  3 3/72 (4.17%)  3 3/72 (4.17%)  3
Anxiety  2/71 (2.82%)  2 9/67 (13.43%)  9 2/71 (2.82%)  2 9/72 (12.50%)  9 4/72 (5.56%)  4
Insomnia  6/71 (8.45%)  6 5/67 (7.46%)  5 4/71 (5.63%)  4 12/72 (16.67%)  12 5/72 (6.94%)  5
Respiratory, thoracic and mediastinal disorders           
Cough  3/71 (4.23%)  3 4/67 (5.97%)  4 1/71 (1.41%)  1 1/72 (1.39%)  1 5/72 (6.94%)  5
Oropharyngeal Pain  4/71 (5.63%)  4 3/67 (4.48%)  3 2/71 (2.82%)  2 2/72 (2.78%)  2 4/72 (5.56%)  4
Skin and subcutaneous tissue disorders           
Rash  1/71 (1.41%)  1 4/67 (5.97%)  4 2/71 (2.82%)  2 3/72 (4.17%)  3 3/72 (4.17%)  3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Josephine Cucchiaro, Executive Director
Organization: Sunovion
Phone: 201-592-2050
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00044044     History of Changes
Other Study ID Numbers: D1050049
First Submitted: August 16, 2002
First Posted: August 20, 2002
Results First Submitted: February 1, 2011
Results First Posted: April 12, 2011
Last Update Posted: April 17, 2014