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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 monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cariprazine | Experimental | Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. |
|
| Placebo | Placebo Comparator | Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. |
|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 | The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix. | Baseline, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Diaz, MD | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 004 | Long Beach | California | 90813 | United States | ||
| Forest Investigative Site 005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31344528 | Derived | McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5. | |
| 29017067 | Derived | Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25. |
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11 participants from 1 investigational site are not included in the analyses due to Good Clinical Practice (GCP) violations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. |
| FG001 | Cariprazine | Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment Phase |
|
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| Placebo | Drug | Patients who meet eligibility criteria will be administered a once daily oral dose of placebo. |
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| Baseline, Week 3 |
| Riverside |
| California |
| 92506 |
| United States |
| Forest Investigative Site 007 | San Diego | California | 92123 | United States |
| Forest Investigative Site 009 | Chicago | Illinois | 60640 | United States |
| Forest Investigative Site 006 | Lake Charles | Louisiana | 70601 | United States |
| Forest Investigative Site 001 | Flowood | Mississippi | 39232 | United States |
| Forest Investigative Site 003 | Creve Couer | Missouri | 63141 | United States |
| Forest Investigative Site 008 | Cleveland | Ohio | 44109 | United States |
| Forest Investigative Site 010 | Oklahoma City | Oklahoma | 73116 | United States |
| Forest Investigative Site 002 | Houston | Texas | 77008 | United States |
| Forest Investigative Site 106 | Vijayawada | Andhra Pradesh | 520002 | India |
| Forest Investigative Site 112 | Vizag | Andhra Pradesh | 530017 | India |
| Forest Investigator Site 108 | Varanasi | Durgakund | 221005 | India |
| Forest Investigative Site 103 | Ahmedabad | Gujarat | 380013 | India |
| Forest Investigative Site 120 | Ahmedabad | Gujarat | 380015 | India |
| Forest Investigative Site 105 | Bangalore | Karnataka | 560010 | India |
| Forest Investigative Site 107 | Bangalore | Karnataka | 560027 | India |
| Forest Investigative Site 118 | Mangalore | Karnataka | 575001 | India |
| Forest Investigative Site 113 | Mangalore | Karnataka | 575018 | India |
| Forest Investigative Site 115 | Manipal | Karnataka | 576104 | India |
| Forest Investigative Site 114 | Mysore | Karnataka | 570004 | India |
| Forest Investigative Site 101 | Aurangabad | Maharashtra | 431005 | India |
| Forest Investigative Site 110 | Nashik | Maharashtra | 422101 | India |
| Forest Investigative Site 111 | Pune | Maharashtra | 411004 | India |
| Forest Investigative Site 104 | Pune | Maharashtra | 411030 | India |
| Forest Investigative Site 121 | Chennai | Tamil Nadu | 600003 | India |
| Forest Investigative Site 109 | Kanpur | Uttar Pradesh | 200005 | India |
| Forest Investigative Site 119 | Lucknow | Uttar Pradesh | 226006 | India |
| COMPLETED |
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| NOT COMPLETED |
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| Safety Follow-up |
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Safety Population included all randomized participants who took at least 1 dose of double-blind investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. |
| BG001 | Cariprazine | Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. |
| BG002 | 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: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/meter(m)^2 |
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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 in the Young Mania Rating Scale (YMRS) Total Score at Week 3 | The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix. | Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 3 |
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| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix. | Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 3 |
|
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First dose of study drug to 30 days past last dose (Up to 51 days)
Safety Population included all randomized participants who took at least 1 dose of double-blind investigational product.
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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 | Placebo | Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. | 5 | 154 | 69 | 154 | ||
| EG001 | Cariprazine | Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. | 6 | 158 | 110 | 158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mania | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Social stay hospitalisation | Social circumstances | MedDRA 14.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Extrapyramidal Disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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All participants from 1 investigative site are excluded due to GCP violations.
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 | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black/African American |
|
| Asian |
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| American Indian or Alaska Native |
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| Other |
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| Participants |
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