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| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
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The objective of this study is 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 | Experimental | Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks. |
|
| 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 |
|---|---|---|
| Raffaele Migliore, MA | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 072 | Little Rock | Arkansas | 72201 | United States | ||
| Forest Investigative Site 021 |
| 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. |
Not provided
Not provided
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cariprazine | Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 48 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Forest Investigative Site 086 | Little Rock | Arkansas | 72211 | United States |
| Forest Investigative Site 014 | Springdale | Arkansas | 72764 | United States |
| Forest Investigative Site 080 | Carson | California | 90746 | United States |
| Forest Investigative Site 079 | Cerritos | California | 90703 | United States |
| Forest Investigative Site 048 | Costa Mesa | California | 92626 | United States |
| Forest Investigative Site 070 | Costa Mesa | California | 92626 | United States |
| Forest Investigative Site 022 | Garden Grove | California | 92845 | United States |
| Forest Investigative Site 083 | Garden Grove | California | 92845 | United States |
| Forest Investigative Site 050 | Long Beach | California | 90813 | United States |
| Forest Investigative Site 006 | Oceanside | California | 92056 | United States |
| Forest Investigative Site 003 | Riverside | California | 92506 | United States |
| Forest Investigative Site 016 | San Diego | California | 92123 | United States |
| Forest Investigative Site 073 | Santa Ana | California | 92701 | United States |
| Forest Investigative Site 071 | New Britain | Connecticut | 06050 | United States |
| Forest Investigative Site 002 | Bradenton | Florida | 34208 | United States |
| Forest Investigative Site 041 | Kissimmee | Florida | 34741 | United States |
| Forest Investigative Site 082 | North Miami | Florida | 33161 | United States |
| Forest Investigative Site 055 | Atlanta | Georgia | 30308 | United States |
| Forest Investigative Site 087 | Atlanta | Georgia | 30308 | United States |
| Forest Investigative Site 012 | Honolulu | Hawaii | 96813 | United States |
| Forest Investigative Site 018 | Chicago | Illinois | 60640 | United States |
| Forest Investigative Site 008 | Hoffman Estates | Illinois | 60169 | United States |
| Forest Investigative Site 044 | Rockville | Maryland | 20850 | United States |
| Forest Investigative Site 007 | Flowood | Mississippi | 39232 | United States |
| Forest Investigative Site 017 | Creve Coeur | Missouri | 63141 | United States |
| Forest Investigative Site 076 | Saint Charles | Missouri | 63301 | United States |
| Forest Investigative Site 045 | St Louis | Missouri | 63118 | United States |
| Forest Investigative Site 052 | Las Vegas | Nevada | 89102 | United States |
| Forest Investigative Site 004 | Willingboro | New Jersey | 08046 | United States |
| Forest Investigative Site 040 | Cedarhurst | New York | 11516 | United States |
| Forest Investigative Site 019 | Willoughby | Ohio | 44094 | United States |
| Forest Investigative Site 077 | Philadelphia | Pennsylvania | 19131 | United States |
| Forest Investigative Site 047 | Philadelphia | Pennsylvania | 19139 | United States |
| Forest Investigative Site 074 | Austin | Texas | 78756 | United States |
| Forest Investigative Site 084 | DeSoto | Texas | 75115 | United States |
| Forest Investigative Site 043 | Irving | Texas | 75062 | United States |
| Forest Investigative Site 078 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 601 | Bello | Antioquia | 051053 | Colombia |
| Forest Investigative Site 604 | Pereira | Risaralda Department | 660003 | Colombia |
| Forest Investigative Site 602 | Bogotá | 110121 | Colombia |
| Forest Investigative Site 605 | Bogotá | 111166 | Colombia |
| Forest Investigative Site 503 | Ahmedabad | 380006 | India |
| Forest Investigative Site 519 | Ahmedabad | 380006 | India |
| Forest Investigative Site 501 | Ahmedabad | 380013 | India |
| Forest Investigative Site 500 | Aurangabad | 431005 | India |
| Forest Investigative Site 507 | Kanpur | 208005 | India |
| Forest Investigative Site 518 | Lucknow | 226006 | India |
| Forest Investigative Site 517 | Mangalore | 575001 | India |
| Forest Investigative Site 515 | Mangalore | 575018 | India |
| Forest Investigative Site 510 | Mumbai | 400026 | India |
| Forest Investigative Site 513 | Nashik | 422101 | India |
| Forest Investigative Site 509 | Rajkot | 360002 | India |
| Forest Investigative Site 506 | Varanasi | 201010 | India |
| Forest Investigative Site 505 | Vijaywada | 520002 | India |
| Forest Investigative Site 306 | Bucharest | 41914 | Romania |
| Forest Investigative Site 301 | Cluj-Napoca | 400012 | Romania |
| Forest Investigative Site 300 | Craiova | 200620 | Romania |
| Forest Investigative Site 311 | Craiova | 200745 | Romania |
| Forest Investigative Site 303 | Targoviste | 130086 | Romania |
| Forest Investigative Site 304 | Târgu Mureş | 540142 | Romania |
| Forest Investigative Site 102 | Arkhangelsk | 163530 | Russia |
| Forest Investigative Site 103 | Chelyabinsk | 454087 | Russia |
| Forest Investigative Site 104 | Chita | 672090 | Russia |
| Forest Investigative Site 112 | Saint Petersburg | 190121 | Russia |
| Forest Investigative Site 105 | Saint Petersburg | 192019 | Russia |
| Forest Investigative Site 106 | Saint Petersburg | 192019 | Russia |
| Forest Investigative Site 113 | Saint Petersburg | 192019 | Russia |
| Forest Investigative Site 107 | Saint Petersburg | 193167 | Russia |
| Forest Investigative Site 109 | Saint Petersburg | 197341 | Russia |
| Forest Investigative Site 110 | Saratov | 410028 | Russia |
| Forest Investigative Site 108 | Saratov | 410060 | Russia |
| Forest Investigative Site 100 | Tomsk | 634014 | Russia |
| Forest Investigative Site 211 | Hlevakha | Kyiv Oblast | 08631 | Ukraine |
| Forest Investigative Site 206 | Kherson | Stepanivka | 73488 | Ukraine |
| Forest Investigative Site 208 | Dnipropetrovsk | 49005 | Ukraine |
| Forest Investigative Site 205 | Dnipropetrovsk | 49027 | Ukraine |
| Forest Investigative Site 200 | Donetsk | 83008 | Ukraine |
| Forest Investigative Site 203 | Kharkiv | 61068 | Ukraine |
| Forest Investigative Site 204 | Kharkiv | 61068 | Ukraine |
| Forest Investigative Site 201 | Kyiv | 04080 | Ukraine |
| Forest Investigative Site 202 | Lviv | 79021 | Ukraine |
| Forest Investigative Site 209 | Poltava | 36006 | Ukraine |
| Forest Investigative Site 210 | Simferopol | 95006 | Ukraine |
| Forest Investigative Site 207 | Vinnytsia | 21005 | 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 |
|
| NOT COMPLETED |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cariprazine | Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks. |
| 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 |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Waist circumference | Summary statistics for this parameter based on 586 patients. | Mean | Standard Deviation | cm |
|
| 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 efficacy assessment. Only participants with data at both Baseline and Week 48 were included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 48 |
|
|
| ||||||||||||||||||||||||||||||||
| 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 efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 48 |
|
|
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.
Not provided
| 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 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks. | 0 | 586 | 59 | 586 | 419 | 586 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Psychotic behaviour | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Social stay hospitalisation | Social circumstances | MedDRA (14.0) | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
|
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 |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C533287 | cariprazine |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|