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| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
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This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo
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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 (RGH-188) | Drug | Cariprazine 3 mg - 12 mg oral administration, once per day. |
| |
| 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 five-point scale (0-4) and 4-items on a nine-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. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate. | 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. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate. |
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Inclusion Criteria:
Male or female inpatients 18 to 65 years of age
Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode
Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For information regarding investigative sites, contact Forest Professional Affairs | St Louis | Missouri | 63045 | United States |
| 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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| 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 | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least 1 dose of study drug.
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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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 five-point scale (0-4) and 4-items on a nine-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. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate. | Intent-to-treat Population included Participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 3 |
First dose of study drug to 30 days past last dose (Up to 51 days)
Safety Population included all participants who received at least 1 dose of study drug.
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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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mania | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| Placebo |
| Drug |
Dose-matched placebo oral administration, once per day. |
|
| Baseline, 3 Weeks |
| Protocol Violation |
|
| Withdrawal of Consent |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| ID | Title | Description |
|---|
| OG000 | Placebo | Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. |
| OG001 | Cariprazine | Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. |
|
|
|
| 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. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate. | 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, LOCF. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 3 Weeks |
|
|
|
|
| 6 |
| 118 |
| 73 |
| 118 |
| EG001 | Cariprazine | Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. | 7 | 118 | 90 | 118 |
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 11.0 | 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.
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |