A Phase 3 interventional study of Cariprazine in Schizophrenia, sponsored by Forest Laboratories. Completed at 86 sites in 6 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 752 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules.
Also known as: RGH-188
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
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
| Milestone | Cariprazine |
|---|---|
| Started | 752 |
| Completed | 226 |
| Not completed | 526 |
| Withdrew: Adverse event | 77 |
| Withdrew: Insufficient therapeutic response | 22 |
| Withdrew: Protocol violation | 45 |
| Withdrew: Withdrawal of consent | 179 |
| Withdrew: Lost to follow-up | 43 |
| Withdrew: Reasons not specified | 27 |
| Withdrew: Did not meet eligibility criteria | 133 |
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.
| Units on a scale | Cariprazine |
|---|---|
| Baseline | 66.5 ± 12.1 |
| Change From Baseline | -5.0 ± 14.0 |
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.
| Units on a scale | Cariprazine |
|---|---|
| Baseline | 3.0 ± 0.4 |
| Change From Baseline | -0.1 ± 0.8 |
Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cariprazine | 0/586 (0%) | 59/586 (10.1%) | 419/586 (71.5%) |
| Event | Cariprazine |
|---|---|
| SchizophreniaPsychiatric disorders | 25/586 |
| Psychotic disorderPsychiatric disorders | 12/586 |
| Social stay hospitalisationSocial circumstances | 6/586 |
| Suicidal ideationPsychiatric disorders | 4/586 |
| Vaginal haemorrhageReproductive system and breast disorders | 1/178 |
| CellulitisInfections and infestations | 2/586 |
| DepressionPsychiatric disorders | 2/586 |
| Hallucination, auditoryPsychiatric disorders | 2/586 |
| Schizophrenia, paranoid typePsychiatric disorders | 2/586 |
| Autoimmune thrombocytopeniaBlood and lymphatic system disorders | 1/586 |
| Event | Cariprazine |
|---|---|
| AkathisiaNervous system disorders | 118/586 |
| HeadacheNervous system disorders | 104/586 |
| InsomniaPsychiatric disorders | 104/586 |
| Weight increasedInvestigations | 79/586 |
| AnxietyPsychiatric disorders | 68/586 |
| NauseaGastrointestinal disorders | 51/586 |
| RestlessnessPsychiatric disorders | 49/586 |
| Extrapyramidal disorderNervous system disorders | 47/586 |
| TremorNervous system disorders | 46/586 |
| DyspepsiaGastrointestinal disorders | 42/586 |
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.
| Age, Continuous(years) | Cariprazine |
|---|---|
| Mean | 39.1 ± 10.8 |
| Sex: Female, Male(Participants) | Cariprazine |
|---|---|
| Female | 178 |
| Male | 408 |
| Ethnicity (NIH/OMB)(Participants) | Cariprazine |
|---|---|
| Hispanic or Latino | 48 |
| Not Hispanic or Latino | 523 |
| Unknown or Not Reported | 15 |
| Race (NIH/OMB)(Participants) | Cariprazine |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 68 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 229 |
| White | 250 |
| More than one race | 0 |
| Unknown or Not Reported | 35 |
| Weight(kg) | Cariprazine |
|---|---|
| Mean | 79.94 ± 20.26 |
| Body Mass Index (BMI)(kg/m^2) | Cariprazine |
|---|---|
| Mean | 27.10 ± 5.80 |
| Waist circumference(cm) | Cariprazine |
|---|---|
| Mean | 91.76 ± 15.85 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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