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| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cariprazine 1.5mg | Experimental | Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine | Drug | Cariprazine was supplied in capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suresh Durgam, MD | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Costa Mesa | California | 92626 | United States | ||
| Forest Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34091867 | Derived | Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6. | |
| 33854317 | Derived | Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cariprazine | Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 48 |
| Long Beach |
| California |
| 90813 |
| United States |
| Forest Investigative Site | Oceanside | California | 92056 | United States |
| Forest Investigative Site | Paramount | California | 90723 | United States |
| Forest Investigative Site | Riverside | California | 92506 | United States |
| Forest Investigative Site | Washington D.C. | District of Columbia | 20016 | United States |
| Forest Investigative Site | Bradenton | Florida | 34208 | United States |
| Forest Investigative Site | Kissimmee | Florida | 34741 | United States |
| Forest Investigative Site | Lake Charles | Louisiana | 70601 | United States |
| Forest Investigative Site | Baltimore | Maryland | 21202 | United States |
| Forest Investigative Site | Flowood | Mississippi | 39232 | United States |
| Forest Investigative Site | Creve Coeur | Missouri | 63141 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45267 | United States |
| Forest Investigative Site | Charleston | South Carolina | 29405 | United States |
| Forest Investigative Site | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site | Houston | Texas | 77008 | United States |
| Forest Investigative Site | Irving | Texas | 75062 | United States |
| Forest Investigative Site | Vijaywada | Andh Prad | 520002 | India |
| Forest Investigative Site | Visakhapatnam | Andh Prad | 530017 | India |
| Forest Investigative Site | Ahmedabad | Gujarat | 380013 | India |
| Forest Investigative Site | Ahmedabad | Gujarat | 380015 | India |
| Forest Investigative Site | Bangalore | Karna | 560010 | India |
| Forest Investigative Site | Bangalore | Karna | 560027 | India |
| Forest Investigative Site | Mangalore | Karna | 574160 | India |
| Forest Investigative Site | Mangalore | Karna | 575001 | India |
| Forest Investigative Site | Manipal | Karna | 576104 | India |
| Forest Investigative Site | Mysore | Karna | 570004 | India |
| Forest Investigative Site | Pune | Mahara | 411004 | India |
| Forest Investigative Site | Jaipur | Rajasthan | 302021 | India |
| Forest Investigative Site | Chennai | Tamil Nadu | 600003 | India |
| Forest Investigative Site | Chennai | Tamil Nadu | 600101 | India |
| Forest Investigative Site | Tirupati | Tamil Nadu | 517507 | India |
| Forest Investigative Site | Kanpur | Uttar Prad | 208005 | India |
| Forest Investigative Site | Johor Bahru | 80100 | Malaysia |
| Forest Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Forest Investigative Site | Perak | 30990 | Malaysia |
| Forest Investigative Site | Arkhangelsk | 163060 | Russia |
| Forest Investigative Site | Gatchina | 188357 | Russia |
| Forest Investigative Site | Ivanovo | 153462 | Russia |
| Forest Investigative Site | Kazan' | 420012 | Russia |
| Forest Investigative Site | Krasnodar | 350007 | Russia |
| Forest Investigative Site 204 | Moscow | 115522 | Russia |
| Forest Investigative Site 206 | Moscow | 115522 | Russia |
| Forest Investigative Site | Moscow | 117152 | Russia |
| Forest Investigative Site | Nizhny Novgorod | 603155 | Russia |
| Forest Investigative Site 214 | Saint Petersburg | 190005 | Russia |
| Forest Investigative Site 217 | Saint Petersburg | 190005 | Russia |
| Forest Investigative Site | Saint Petersburg | 190121 | Russia |
| Forest Investigative Site | Saint Petersburg | 191119 | Russia |
| Forest Investigative Site 202 | Saint Petersburg | 193019 | Russia |
| Forest Investigative Site 203 | Saint Petersburg | 193019 | Russia |
| Forest Investigative Site | Saint Petersburg | 193167 | Russia |
| Forest Investigative Site | Saint Petersburg | 197341 | Russia |
| Forest Investigative Site | Samara | 443016 | Russia |
| Forest Investigative Site | Kherson | Vil. Stepanivka | 73488 | Ukraine |
| Forest Investigative Site | Chernihiv | 14000 | Ukraine |
| Forest Investigative Site | Dnipropetrovsk | 49616 | Ukraine |
| Forest Investigative Site | Donetsk | 83037 | Ukraine |
| Forest Investigative Site | Hlevakha | 8630 | Ukraine |
| Forest Investivative Site | Kharkiv | 61068 | Ukraine |
| Forest Investigative Site | Kiev | 2660 | Ukraine |
| Forest Investigative Site | Kyiv | 4080 | Ukraine |
| Forest Investigative Site | Kyiv | 4655 | Ukraine |
| Forest Investigative Site | Odesa | 65006 | Ukraine |
| Forest Investigative Site | Ternopil | 46020 | Ukraine |
| 28836957 | Derived | Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: All enrolled participants who took at least 1 dose of cariprazine.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cariprazine | Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Height | Mean | Standard Deviation | cm |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Waist circumference | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | Units on a scale | Baseline to Week 48 |
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| 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. | 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. | Posted | Mean | Standard Error | Units on a scale | Baseline to Week 48 |
|
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Baseline to Week 52
Safety population: All enrolled participants who took at least 1 dose of cariprazine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cariprazine | Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability | 0 | 93 | 12 | 93 | 62 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
| |
| Adjustment disorder | Renal and urinary disorders | MedDRA 12.0 or newer | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Social stay hospitalisation | Social circumstances | MedDRA 12.0 or newer | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Filariasis | Infections and infestations | MedDRA 12.0 or newer | Systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA 12.0 or newer | Systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 12.0 or newer | Systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 12.0 or newer | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 or newer | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 12.0 or newer | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 or newer | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Willie R. Earley, MD Associate Vice President Clinical Development-CNS | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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|