Trial Outcomes & Findings for Long-term Study of Cariprazine in Patients With Schizophrenia (NCT NCT01104792)
NCT ID: NCT01104792
Last Updated: 2019-07-26
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
752 participants
Primary outcome timeframe
Baseline to Week 48
Results posted on
2019-07-26
Participant Flow
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability.
Participant milestones
| Measure |
Cariprazine
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
752
|
|
Overall Study
COMPLETED
|
226
|
|
Overall Study
NOT COMPLETED
|
526
|
Reasons for withdrawal
| Measure |
Cariprazine
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
77
|
|
Overall Study
Insufficient Therapeutic Response
|
22
|
|
Overall Study
Protocol Violation
|
45
|
|
Overall Study
Withdrawal of Consent
|
179
|
|
Overall Study
Lost to Follow-up
|
43
|
|
Overall Study
Reasons Not Specified
|
27
|
|
Overall Study
Did Not Meet Eligibility Criteria
|
133
|
Baseline Characteristics
Long-term Study of Cariprazine in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Cariprazine
n=586 Participants
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
|
|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
408 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
523 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
250 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
|
Weight
|
79.94 kg
STANDARD_DEVIATION 20.26 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.10 kg/m^2
STANDARD_DEVIATION 5.80 • n=5 Participants
|
|
Waist circumference
|
91.76 cm
STANDARD_DEVIATION 15.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 48Population: Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline efficacy assessment. Only participants with data at both Baseline and Week 48 were included in the analysis.
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
Outcome measures
| Measure |
Cariprazine
n=572 Participants
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
|
|---|---|
|
Change From Baseline to Week 48 in the PANSS Total Score
Baseline
|
66.5 Units on a scale
Standard Deviation 12.1
|
|
Change From Baseline to Week 48 in the PANSS Total Score
Change From Baseline
|
-5.0 Units on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline efficacy assessment.
The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.
Outcome measures
| Measure |
Cariprazine
n=578 Participants
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
|
|---|---|
|
Change From Baseline to Week 48 in the CGI-S Score
Baseline
|
3.0 Units on a scale
Standard Deviation 0.4
|
|
Change From Baseline to Week 48 in the CGI-S Score
Change From Baseline
|
-0.1 Units on a scale
Standard Deviation 0.8
|
Adverse Events
Cariprazine
Serious events: 59 serious events
Other events: 419 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cariprazine
n=586 participants at risk
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
General disorders
Medical device pain
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
General disorders
Non-cardiac chest pain
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Infections and infestations
Cellulitis
|
0.34%
2/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Infections and infestations
Appendicitis
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Infections and infestations
Tracheobronchitis
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Brain injury
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Schizophrenia
|
4.3%
25/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Psychotic disorder
|
2.0%
12/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Suicidal ideation
|
0.68%
4/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Depression
|
0.34%
2/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.34%
2/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.34%
2/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Aggression
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Agitation
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Homicidal ideation
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Paranoia
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Psychotic behaviour
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.56%
1/178 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Social circumstances
Social stay hospitalisation
|
1.0%
6/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Surgical and medical procedures
Hospitalisation
|
0.17%
1/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
Other adverse events
| Measure |
Cariprazine
n=586 participants at risk
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
8.7%
51/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.2%
42/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
33/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Gastrointestinal disorders
Toothache
|
5.3%
31/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
30/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
30/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Investigations
Weight increased
|
13.5%
79/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.0%
35/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Akathisia
|
20.1%
118/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Headache
|
17.7%
104/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Extrapyramidal disorder
|
8.0%
47/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Tremor
|
7.8%
46/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Nervous system disorders
Dizziness
|
5.5%
32/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Insomnia
|
17.7%
104/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Anxiety
|
11.6%
68/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
|
Psychiatric disorders
Restlessness
|
8.4%
49/586 • 52 weeks
The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability. Safety population: All enrolled participants who took at least 1 dose of cariprazine.
|
Additional Information
Willie R. Earley, MD Associate Vice President Clinical Development-CNS
Allergan
Phone: 714-246-4500
Email: [email protected],
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER