Schizophrenia
Conditions
Brief summary
This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
Interventions
DRUGCariprazine
Cariprazine was supplied in capsules.
Sponsors
Gedeon Richter Ltd.
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707) * Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3. * Patients eligible to continue as outpatients based on the opinion of the Principal Investigator. * Patients must have a caregiver to ensure treatment compliance.
Exclusion criteria
* Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 48 in the PANSS Total Score | Baseline to Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 48 in the CGI-S Score | Baseline to Week 48 | 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. |
Countries
India, Malaysia, Russia, Ukraine, United States
Participant flow
Recruitment details
The Enrolled Population consisted of 97 participants who completed the lead-in study, RGH-MD-16, and signed an informed consent form to continue in this extension study. The Safety Population consisted of 93 participants from the Enrolled Population who took at least 1 dose of cariprazine in this extension study.
Pre-assignment details
The study was designed as a one-arm study where patients were not randomized or analyzed by dose, rather they were flexibly dosed with Cariprazine 1.5, 3.0, or 4.5 mg/day via oral administration. The starting dose of 1.5 mg/day was titrated as needed within the range of 1.5-4.5 mg/d based on investigator's judgment of response and tolerability.
Participants by arm
| Arm | Count |
|---|---|
| Cariprazine Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Insufficient Therapeutic Response | 3 |
| Overall Study | Lack of Compliance While in Jail | 1 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 9 |
| Overall Study | Withdrawal of Consent | 16 |
Baseline characteristics
| Characteristic | Cariprazine |
|---|---|
| Age, Continuous | 34.4 years STANDARD_DEVIATION 10.1 |
| Body Mass Index (BMI) | 24.99 kg/m^2 STANDARD_DEVIATION 4.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 169.09 cm STANDARD_DEVIATION 10.73 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 52 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 63 Participants |
| Waist circumference | 84.90 cm STANDARD_DEVIATION 11.19 |
| Weight | 72.19 kg STANDARD_DEVIATION 17.66 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 93 |
| other Total, other adverse events | 62 / 93 |
| serious Total, serious adverse events | 12 / 93 |
Outcome results
Primary
Change From Baseline to Week 48 in the PANSS Total Score
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.
Time frame: Baseline to Week 48
Population: Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline assessment of the PANSS total score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cariprazine | Change From Baseline to Week 48 in the PANSS Total Score | -38.5 Units on a scale | Standard Error 1.5 |
Secondary
Change From Baseline to Week 48 in the CGI-S Score
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.
Time frame: Baseline to Week 48
Population: Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline assessment of the PANSS total score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cariprazine | Change From Baseline to Week 48 in the CGI-S Score | -2.0 Units on a scale | Standard Error 0.1 |