Trial Outcomes & Findings for A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia (NCT NCT00044044)
NCT ID: NCT00044044
Last Updated: 2014-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
356 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2014-04-17
Participant Flow
Participant milestones
| Measure |
20 mg
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.
|
40 mg
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.
|
80 mg
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
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.
|
Placebo
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
69
|
71
|
73
|
72
|
|
Overall Study
COMPLETED
|
27
|
28
|
31
|
29
|
36
|
|
Overall Study
NOT COMPLETED
|
44
|
41
|
40
|
44
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
20 mg
n=71 Participants
Lurasidone 20 mg oral tablet taken once a day
|
40 mg
n=67 Participants
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.
|
80 mg
n=71 Participants
Lurasidone 80 mg oral tablet taken once a day
|
10 mg Haloperidol
n=72 Participants
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.
|
Placebo
n=72 Participants
Oral Capsule matching treatment group taken oce a day
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 10.5 • n=93 Participants
|
42.0 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
42.2 years
STANDARD_DEVIATION 8.3 • n=27 Participants
|
40.0 years
STANDARD_DEVIATION 10.5 • n=483 Participants
|
41.0 years
STANDARD_DEVIATION 9.7 • n=36 Participants
|
41.2 years
STANDARD_DEVIATION 10.0 • n=10 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
91 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
55 Participants
n=36 Participants
|
262 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
20 mg
n=71 Participants
Lurasidone 20 mg oral tablet taken once a day
|
40 mg
n=65 Participants
Lurasidone 40 mg oral tablet taken once a day
|
80 mg
n=70 Participants
Lurasidone 80 mg oral tablet taken once a day
|
10 mg Haloperidol
n=72 Participants
10 mg Haloperidol overencapsulated tablet taken orally once a day
|
Placebo
n=71 Participants
Oral Capsule matching treatment group taken oce a day
|
|---|---|---|---|---|---|
|
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
|
-5.0 units on a scale
Standard Error 1.38
|
-5.2 units on a scale
Standard Error 1.44
|
-8.0 units on a scale
Standard Error 1.40
|
-9.8 units on a scale
Standard Error 1.37
|
-7.9 units on a scale
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
20 mg
n=71 Participants
Lurasidone 20 mg oral tablet taken once a day
|
40 mg
n=65 Participants
Lurasidone 40 mg oral tablet taken once a day
|
80 mg
n=70 Participants
Lurasidone 80 mg oral tablet taken once a day
|
10 mg Haloperidol
n=72 Participants
10 mg Haloperidol overencapsulated tablet taken orally once a day
|
Placebo
n=71 Participants
Oral Capsule matching treatment group taken oce a day
|
|---|---|---|---|---|---|
|
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
|
-7.1 units on a scale
Standard Error 2.31
|
-7.2 units on a scale
Standard Error 2.42
|
-13.6 units on a scale
Standard Error 2.34
|
-16.0 units on a scale
Standard Error 2.29
|
-12.3 units on a scale
Standard Error 2.32
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
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).
Outcome measures
| Measure |
20 mg
n=71 Participants
Lurasidone 20 mg oral tablet taken once a day
|
40 mg
n=64 Participants
Lurasidone 40 mg oral tablet taken once a day
|
80 mg
n=70 Participants
Lurasidone 80 mg oral tablet taken once a day
|
10 mg Haloperidol
n=71 Participants
10 mg Haloperidol overencapsulated tablet taken orally once a day
|
Placebo
n=71 Participants
Oral Capsule matching treatment group taken oce a day
|
|---|---|---|---|---|---|
|
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
|
-0.5 units on a scale
Standard Error 0.11
|
-0.4 units on a scale
Standard Error 0.12
|
-0.8 units on a scale
Standard Error 0.12
|
-0.8 units on a scale
Standard Error 0.12
|
-0.7 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
20 mg
n=71 Participants
Lurasidone 20 mg oral tablet taken once a day
|
40 mg
n=64 Participants
Lurasidone 40 mg oral tablet taken once a day
|
80 mg
n=70 Participants
Lurasidone 80 mg oral tablet taken once a day
|
10 mg Haloperidol
n=72 Participants
10 mg Haloperidol overencapsulated tablet taken orally once a day
|
Placebo
n=71 Participants
Oral Capsule matching treatment group taken oce a day
|
|---|---|---|---|---|---|
|
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
|
-1.3 units on scale
Standard Error 0.97
|
-1.1 units on scale
Standard Error 1.02
|
-2.5 units on scale
Standard Error 0.98
|
-2.7 units on scale
Standard Error 0.96
|
-1.9 units on scale
Standard Error 0.97
|
Adverse Events
20 mg
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
40 mg
Serious events: 9 serious events
Other events: 51 other events
Deaths: 0 deaths
80 mg
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
10 mg Haloperidol
Serious events: 5 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20 mg
n=71 participants at risk
Lurasidone 20 mg oral tablet taken once a day
|
40 mg
n=67 participants at risk
Lurasidone 40 mg oral tablet taken once a day
|
80 mg
n=71 participants at risk
Lurasidone 80 mg oral tablet taken once a day
|
10 mg Haloperidol
n=72 participants at risk
10 mg Haloperidol overencapsulated tablet taken orally once a day
|
Placebo
n=72 participants at risk
Oral Capsule matching treatment group taken oce a day
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
1.4%
1/71 • Number of events 1
|
0.00%
0/67
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/72
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/71
|
0.00%
0/67
|
0.00%
0/71
|
0.00%
0/72
|
1.4%
1/72 • Number of events 1
|
|
Psychiatric disorders
Abnormal Behavior
|
0.00%
0/71
|
0.00%
0/67
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/72
|
|
Psychiatric disorders
Agitation
|
0.00%
0/71
|
0.00%
0/67
|
0.00%
0/71
|
0.00%
0/72
|
1.4%
1/72 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/71
|
0.00%
0/67
|
1.4%
1/71 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
0.00%
0/72
|
|
Psychiatric disorders
Schizophrenia
|
2.8%
2/71 • Number of events 2
|
11.9%
8/67 • Number of events 8
|
2.8%
2/71 • Number of events 2
|
4.2%
3/72 • Number of events 3
|
5.6%
4/72 • Number of events 4
|
|
Psychiatric disorders
Suicidal Ideation
|
1.4%
1/71 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
0.00%
0/71
|
2.8%
2/72 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
Other adverse events
| Measure |
20 mg
n=71 participants at risk
Lurasidone 20 mg oral tablet taken once a day
|
40 mg
n=67 participants at risk
Lurasidone 40 mg oral tablet taken once a day
|
80 mg
n=71 participants at risk
Lurasidone 80 mg oral tablet taken once a day
|
10 mg Haloperidol
n=72 participants at risk
10 mg Haloperidol overencapsulated tablet taken orally once a day
|
Placebo
n=72 participants at risk
Oral Capsule matching treatment group taken oce a day
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.4%
1/71 • Number of events 1
|
0.00%
0/67
|
0.00%
0/71
|
6.9%
5/72 • Number of events 5
|
1.4%
1/72 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.8%
2/71 • Number of events 2
|
1.5%
1/67 • Number of events 1
|
8.5%
6/71 • Number of events 6
|
4.2%
3/72 • Number of events 3
|
12.5%
9/72 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
3/71 • Number of events 3
|
3.0%
2/67 • Number of events 2
|
2.8%
2/71 • Number of events 2
|
4.2%
3/72 • Number of events 3
|
6.9%
5/72 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
11.3%
8/71 • Number of events 8
|
9.0%
6/67 • Number of events 6
|
11.3%
8/71 • Number of events 8
|
6.9%
5/72 • Number of events 5
|
9.7%
7/72 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
11.3%
8/71 • Number of events 8
|
10.4%
7/67 • Number of events 7
|
18.3%
13/71 • Number of events 13
|
5.6%
4/72 • Number of events 4
|
11.1%
8/72 • Number of events 8
|
|
Gastrointestinal disorders
Toothache
|
2.8%
2/71 • Number of events 2
|
1.5%
1/67 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
5.6%
4/72 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
5/71 • Number of events 5
|
7.5%
5/67 • Number of events 5
|
16.9%
12/71 • Number of events 12
|
5.6%
4/72 • Number of events 4
|
6.9%
5/72 • Number of events 5
|
|
General disorders
Fatigue
|
7.0%
5/71 • Number of events 5
|
3.0%
2/67 • Number of events 2
|
12.7%
9/71 • Number of events 9
|
9.7%
7/72 • Number of events 7
|
4.2%
3/72 • Number of events 3
|
|
General disorders
Pain
|
1.4%
1/71 • Number of events 1
|
6.0%
4/67 • Number of events 4
|
2.8%
2/71 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
6.9%
5/72 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
3/71 • Number of events 3
|
3.0%
2/67 • Number of events 2
|
1.4%
1/71 • Number of events 1
|
5.6%
4/72 • Number of events 4
|
2.8%
2/72 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/71
|
6.0%
4/67 • Number of events 4
|
2.8%
2/71 • Number of events 2
|
5.6%
4/72 • Number of events 4
|
1.4%
1/72 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/71
|
6.0%
4/67 • Number of events 4
|
7.0%
5/71 • Number of events 5
|
5.6%
4/72 • Number of events 4
|
2.8%
2/72 • Number of events 2
|
|
Nervous system disorders
Akathisia
|
5.6%
4/71 • Number of events 4
|
13.4%
9/67 • Number of events 9
|
18.3%
13/71 • Number of events 13
|
19.4%
14/72 • Number of events 14
|
9.7%
7/72 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
5.6%
4/71 • Number of events 4
|
4.5%
3/67 • Number of events 3
|
5.6%
4/71 • Number of events 4
|
4.2%
3/72 • Number of events 3
|
4.2%
3/72 • Number of events 3
|
|
Nervous system disorders
Dystonia
|
0.00%
0/71
|
1.5%
1/67 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
12.5%
9/72 • Number of events 9
|
1.4%
1/72 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal Disorder
|
4.2%
3/71 • Number of events 3
|
6.0%
4/67 • Number of events 4
|
5.6%
4/71 • Number of events 4
|
18.1%
13/72 • Number of events 13
|
4.2%
3/72 • Number of events 3
|
|
Nervous system disorders
Headache
|
21.1%
15/71 • Number of events 15
|
23.9%
16/67 • Number of events 16
|
23.9%
17/71 • Number of events 17
|
19.4%
14/72 • Number of events 14
|
33.3%
24/72 • Number of events 24
|
|
Nervous system disorders
Sedation
|
11.3%
8/71 • Number of events 8
|
16.4%
11/67 • Number of events 11
|
21.1%
15/71 • Number of events 15
|
20.8%
15/72 • Number of events 15
|
8.3%
6/72 • Number of events 6
|
|
Nervous system disorders
Somnolence
|
4.2%
3/71 • Number of events 3
|
6.0%
4/67 • Number of events 4
|
9.9%
7/71 • Number of events 7
|
12.5%
9/72 • Number of events 9
|
5.6%
4/72 • Number of events 4
|
|
Nervous system disorders
Tremor
|
1.4%
1/71 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
0.00%
0/71
|
6.9%
5/72 • Number of events 5
|
1.4%
1/72 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
9.9%
7/71 • Number of events 7
|
13.4%
9/67 • Number of events 9
|
4.2%
3/71 • Number of events 3
|
4.2%
3/72 • Number of events 3
|
4.2%
3/72 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
2.8%
2/71 • Number of events 2
|
13.4%
9/67 • Number of events 9
|
2.8%
2/71 • Number of events 2
|
12.5%
9/72 • Number of events 9
|
5.6%
4/72 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
8.5%
6/71 • Number of events 6
|
7.5%
5/67 • Number of events 5
|
5.6%
4/71 • Number of events 4
|
16.7%
12/72 • Number of events 12
|
6.9%
5/72 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
3/71 • Number of events 3
|
6.0%
4/67 • Number of events 4
|
1.4%
1/71 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
6.9%
5/72 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.6%
4/71 • Number of events 4
|
4.5%
3/67 • Number of events 3
|
2.8%
2/71 • Number of events 2
|
2.8%
2/72 • Number of events 2
|
5.6%
4/72 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/71 • Number of events 1
|
6.0%
4/67 • Number of events 4
|
2.8%
2/71 • Number of events 2
|
4.2%
3/72 • Number of events 3
|
4.2%
3/72 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place