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| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
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The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cariprazine (3-6 mg/day) | Experimental | Cariprazine once daily fixed-flexible low dose |
|
| Cariprazine (6-9 mg/day) | Experimental | Cariprazine once daily fixed-flexible high dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine | Drug | Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S) | The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater 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 48 | Costa Mesa | California | 92626 | United States | ||
| Forest Investigative Site 50 |
| 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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Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. No-drug washout period of up to 7 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Oral administration. Once per day. |
| FG001 | Cariprazine (3-6 mg/Day) | Oral administration. Once per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
|
| Baseline to Week 6 |
| Long Beach |
| California |
| 90813 |
| United States |
| Forest Investigative Site 42 | Paramount | California | 90723 | United States |
| Forest Investigative Site 054 | San Diego | California | 92102 | United States |
| Forest Investigative Site 41 | Kissimmee | Florida | 34741 | United States |
| Forest Investigative Site 055 | Atlanta | Georgia | 30308 | United States |
| Forest Investigative Site 44 | Rockville | Maryland | 20850 | United States |
| Forest Investigative Site 45 | St Louis | Missouri | 63118 | United States |
| Forest Investigative Site 52 | Las Vegas | Nevada | 89102 | United States |
| Forest Investigative Site 40 | Cedarhurst | New York | 11516 | United States |
| Forest Investigative Site 46 | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site 47 | Philadelphia | Pennsylvania | 19139 | United States |
| Forest Investigative 49 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 51 | Houston | Texas | 77021 | United States |
| Forest Investigative Site 43 | Irving | Texas | 75062 | 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 505 | Vijayawada | Andhra Pradesh | 520002 | India |
| Forest Investigative Site 514 | Visakhapatnam | Andhra Pradesh | 530017 | India |
| Forest Investigative Site 503 | Ahmedabad | Gujarat | 380006 | India |
| Forest Investigative Site 519 | Ahmedabad | Gujarat | 380006 | India |
| Forest Investigative Site 501 | Ahmedabad | Gujarat | 380013 | India |
| Forest Investigative Site 508 | Ahmedabad | Gujarat | 380015 | India |
| Forest Investigative Site 504 | Bangalore | Karna | 560010 | India |
| Forest Investigative Site 517 | Mangalore | Karna | 575001 | India |
| Forest Investigative Site 515 | Mangalore | Karna | 575018 | India |
| Forest Investigative Site 516 | Mysore | Karna | 570015 | India |
| Forest Investigative Site 500 | Aurangabad | Mahara | 431005 | India |
| Forest Investigative Site 510 | Mumbai | Mahara | 400026 | India |
| Forest Investigative Site 513 | Nashik | Mahara | 422101 | India |
| Forest Investigative Site 511 | Pune | Mahara | 411001 | India |
| Forest Investigative Site 502 | Pune | Mahara | 411030 | India |
| Forest Investigative Site 509 | Rajkot | Rajasthan | 360002 | India |
| Forest Investigative Site 507 | Kanpur | Uttar Pradesh | 208005 | India |
| Forest Investigative Site 518 | Lucknow | Uttar Pradesh | 226006 | India |
| Forest Investigative Site 506 | Varanasi | Uttar Pradesh | 201010 | India |
| Forest Investigative Site 704 | Johannesburg | Gauteng | 2198 | South Africa |
| Forest Investigative Site 703 | Cape Town | W Cape | 7530 | South Africa |
| Forest Investigative Site 706 | Cape Town | W Cape | 7535 | South Africa |
| 30470662 | Derived | Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20. |
| 28692485 | Derived | Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187. |
| 28478771 | Derived | Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8. |
| 26845266 | Derived | Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192. |
| FG002 |
| Cariprazine (6-9 mg/Day) |
Oral administration. Once per day. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The randomized population is also the safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Oral administration. Once per day. |
| BG001 | Cariprazine (3-6 mg/Day) | Oral administration. Once per day. |
| BG002 | Cariprazine (6-9 mg/Day) | Oral administration. Once per day. |
| BG003 | Total | Total of all reporting groups |
| 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/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement. | Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline to Week 6 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S) | The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement. | Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 6 |
|
Adverse Events were collected for 8 weeks.
Safety Population: All patients in the randomized population who took at least 1 dose of double-blind investigational product.
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 | Placebo | Oral administration. Once per day. | 0 | 147 | 13 | 161 | 54 | 147 |
| EG001 | Cariprazine (3-6 mg/Day) | Oral administration. Once per day. | 0 | 151 | 9 | 167 | 84 | 151 |
| EG002 | Cariprazine (6-9 mg/Day) | Oral administration. Once per day. | 0 | 148 | 4 | 169 | 86 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic disorder | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Polydipsia psychogenic | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 14.1 | 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 | |
|---|---|---|---|---|
| Medical Director | Allergan | 877-277-8566 | IR-CTRegistration@Allergan.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
Not provided
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| Female |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African-American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| <0.0001 |
| Mean Difference (Final Values) |
| -9.9 |
| 2-Sided |
| 95 |
| -14.5 |
| -5.3 |
Cariprazine 6-9 mg/day vs Placebo |
| Superiority |
| Units | Counts |
|---|
| Participants |
|
|
|