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Safety and Efficacy of Cariprazine in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01104779
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Cariprazine
Drug: Placebo
Enrollment 446
Recruitment Details  
Pre-assignment Details Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. No-drug washout period of up to 7 days.
Arm/Group Title Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day)
Hide Arm/Group Description Oral administration. Once per day. Oral administration. Once per day. Oral administration. Once per day.
Period Title: Overall Study
Started 147 151 148
Completed 88 96 86
Not Completed 59 55 62
Reason Not Completed
Protocol Violation             1             2             2
Lack of Efficacy             26             12             13
Adverse Event             13             14             13
Did not meet inc/exc criteria             1             1             1
Other reasons             0             1             0
Lost to Follow-up             2             0             1
Withdrawal by Subject             16             25             32
Arm/Group Title Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day) Total
Hide Arm/Group Description Oral administration. Once per day. Oral administration. Once per day. Oral administration. Once per day. Total of all reporting groups
Overall Number of Baseline Participants 147 151 148 446
Hide Baseline Analysis Population Description
The randomized population is also the safety population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 151 participants 148 participants 446 participants
36.7  (11.3) 36.6  (10.5) 35.5  (9.3) 36.3  (10.4)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 151 participants 148 participants 446 participants
Male
110
  74.8%
118
  78.1%
113
  76.4%
341
  76.5%
Female
37
  25.2%
33
  21.9%
35
  23.6%
105
  23.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 151 participants 148 participants 446 participants
Hispanic or Latino
23
  15.6%
24
  15.9%
27
  18.2%
74
  16.6%
Not Hispanic or Latino
124
  84.4%
127
  84.1%
121
  81.8%
372
  83.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 151 participants 148 participants 446 participants
White
26
  17.7%
28
  18.5%
30
  20.3%
84
  18.8%
Black or African-American
51
  34.7%
56
  37.1%
53
  35.8%
160
  35.9%
Asian
56
  38.1%
56
  37.1%
56
  37.8%
168
  37.7%
American Indian or Alaska Native
1
   0.7%
1
   0.7%
1
   0.7%
3
   0.7%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
2
   1.4%
3
   0.7%
Other
12
   8.2%
10
   6.6%
6
   4.1%
28
   6.3%
1.Primary Outcome
Title Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.
Arm/Group Title Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day)
Hide Arm/Group Description:
Oral administration. Once per day.
Oral administration. Once per day.
Oral administration. Once per day.
Overall Number of Participants Analyzed 145 147 147
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-16.0  (1.6) -22.8  (1.6) -25.9  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine (3-6 mg/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.8
Confidence Interval (2-Sided) 95%
-11.3 to -2.4
Estimation Comments Cariprazine 3-6 mg/day vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine (6-9 mg/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.9
Confidence Interval (2-Sided) 95%
-14.5 to -5.3
Estimation Comments Cariprazine 6-9 mg/day vs Placebo
2.Secondary Outcome
Title Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Hide Description The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.
Arm/Group Title Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day)
Hide Arm/Group Description:
Oral administration. Once per day.
Oral administration. Once per day.
Oral administration. Once per day.
Overall Number of Participants Analyzed 145 147 147
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.0  (0.1) -1.4  (0.1) -1.6  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine (3-6 mg/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.6 to -0.1
Estimation Comments Cariprazine 3-6 mg/day vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine (6-9 mg/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.8 to -0.3
Estimation Comments Cariprazine 6-9 mg/day vs Placebo
Time Frame Adverse Events were collected for 8 weeks.
Adverse Event Reporting Description Safety Population: All patients in the randomized population who took at least 1 dose of double-blind investigational product.
 
Arm/Group Title Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day)
Hide Arm/Group Description Oral administration. Once per day. Oral administration. Once per day. Oral administration. Once per day.
All-Cause Mortality
Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/147 (0.00%)   0/151 (0.00%)   0/148 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/161 (8.07%)   9/167 (5.39%)   4/169 (2.37%) 
Cardiac disorders       
Angina pectoris  1  0/161 (0.00%)  0/167 (0.00%)  1/169 (0.59%) 
Hepatobiliary disorders       
Hepatitis  1  0/161 (0.00%)  0/167 (0.00%)  1/169 (0.59%) 
Investigations       
Blood pressure increased  1  0/161 (0.00%)  0/167 (0.00%)  1/169 (0.59%) 
Heart rate irregular  1  0/161 (0.00%)  0/167 (0.00%)  1/169 (0.59%) 
Metabolism and nutrition disorders       
Hyponatraemia  1  1/161 (0.62%)  1/167 (0.60%)  0/169 (0.00%) 
Nervous system disorders       
Psychomotor hyperactivity  1  3/161 (1.86%)  3/167 (1.80%)  0/169 (0.00%) 
Psychiatric disorders       
Psychotic disorder  1  2/161 (1.24%)  4/167 (2.40%)  1/169 (0.59%) 
Schizophrenia  1  6/161 (3.73%)  2/167 (1.20%)  0/169 (0.00%) 
Anxiety  1  1/161 (0.62%)  0/167 (0.00%)  0/169 (0.00%) 
Polydipsia psychogenic  1  1/161 (0.62%)  0/167 (0.00%)  0/169 (0.00%) 
Schizophrenia, paranoid type  1  1/161 (0.62%)  0/167 (0.00%)  0/169 (0.00%) 
Suicidal ideation  1  1/161 (0.62%)  0/167 (0.00%)  0/169 (0.00%) 
1
Term from vocabulary, MedDRA 14.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Cariprazine (3-6 mg/Day) Cariprazine (6-9 mg/Day)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/147 (36.73%)   84/151 (55.63%)   86/148 (58.11%) 
Gastrointestinal disorders       
Nausea  1  7/147 (4.76%)  7/151 (4.64%)  14/148 (9.46%) 
Constipation  1  5/147 (3.40%)  14/151 (9.27%)  10/148 (6.76%) 
Dyspepsia  1  6/147 (4.08%)  3/151 (1.99%)  10/148 (6.76%) 
Vomiting  1  4/147 (2.72%)  8/151 (5.30%)  8/148 (5.41%) 
Diarrhoea  1  2/147 (1.36%)  8/151 (5.30%)  6/148 (4.05%) 
Investigations       
Weight increased  1  2/147 (1.36%)  5/151 (3.31%)  8/148 (5.41%) 
Nervous system disorders       
Akathisia  1  5/147 (3.40%)  24/151 (15.89%)  25/148 (16.89%) 
Headache  1  19/147 (12.93%)  14/151 (9.27%)  24/148 (16.22%) 
Extrapyramidal disorder  1  4/147 (2.72%)  8/151 (5.30%)  15/148 (10.14%) 
Tremor  1  3/147 (2.04%)  12/151 (7.95%)  8/148 (5.41%) 
Psychiatric disorders       
Insomnia  1  16/147 (10.88%)  10/151 (6.62%)  16/148 (10.81%) 
Restlessness  1  7/147 (4.76%)  10/151 (6.62%)  15/148 (10.14%) 
1
Term from vocabulary, MedDRA 14.1
Indicates events were collected by systematic assessment
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.
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Allergan
Phone: 877-277-8566
EMail: IR‐CTRegistration@Allergan.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01104779     History of Changes
Other Study ID Numbers: RGH-MD-05
First Submitted: April 14, 2010
First Posted: April 15, 2010
Results First Submitted: July 6, 2018
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018