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| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing. |
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| 2 | Experimental | 1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing. |
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| 3 | Placebo Comparator | Matching placebo capsules, oral administration, once daily dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cariprazine | Drug | Drug: cariprazine (0.25 - 0.75 mg/day) |
| |
| cariprazine |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) | The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I ) | The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse. | Baseline to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Greenberg, MD | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 005 | Encino | California | 91316 | United States | ||
| Forest Investigative Site 017 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31969269 | Derived | Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22. |
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233 patients were randomized to receive double-blind treatment, 227 patients received at least 1 dose of double-blind treatment and were included in safety Population
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo capsules, orally administered for 8 weeks |
| FG001 | 0.25 to 0.75 mg Cariprazine | Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Drug: cariprazine (1.5 - 3.0 mg/day) |
|
| placebo | Drug | placebo capsules, oral administration, once daily dosing |
|
| Garden Grove |
| California |
| 92845 |
| United States |
| Forest Investigative Site 027 | National City | California | 91950 | United States |
| Forest Investigative Site 013 | Newport Beach | California | 92660 | United States |
| Forest Investigative Site 010 | Oceanside | California | 92056 | United States |
| Forest Investigative Site 020 | Bradenton | Florida | 34208 | United States |
| Forest Investigative Site 007 | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site 019 | Kissimmee | Florida | 34741 | United States |
| Forest Investigative Site 026 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 012 | West Palm Beach | Florida | 33407 | United States |
| Forest Investigative Site 024 | Glen Burnie | Maryland | 21061 | United States |
| Forest Investigative Site 029 | Creve Coeur | Missouri | 63141 | United States |
| Forest Investigative Site 002 | Omaha | Nebraska | 68131 | United States |
| Forest Investigative Site 028 | Cherry Hill | New Jersey | 08002 | United States |
| Forest Investigative Site 001 | The Bronx | New York | 10467 | United States |
| Forest Investigative Site 018 | Durham | North Carolina | 27710 | United States |
| Forest Investigative Site 004 | Dayton | Ohio | 45417 | United States |
| Forest Investigative Site 022 | Mason | Ohio | 45040 | United States |
| Forest Investigative Site 015 | Portland | Oregon | 97210 | United States |
| Forest Investigative Site 006 | Media | Pennsylvania | 19063 | United States |
| Forest Investigative Site 011 | Philadelphia | Pennsylvania | 19107 | United States |
| Forest Investigative Site 014 | Nashville | Tennessee | 37212 | United States |
| Forest Investigative Site 023 | Irving | Texas | 75062 | United States |
| Forest Investigative Site 003 | Woodstock | Vermont | 05091 | United States |
| Forest Investigative Site 009 | Bellevue | Washington | 98004 | United States |
| Forest Investigative Site 016 | Seattle | Washington | 98104 | United States |
| FG002 | 1.5 to 3.0 mg Cariprazine | 1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo capsules, orally administered for 8 weeks |
| BG001 | 0.25 to 0.75 mg Cariprazine | Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks |
| BG002 | 1.5 to 3.0 mg Cariprazine | Cariprazine capsules 1.5 to 3.0 mg was orally administrated once daily for 8 weeks |
| 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 |
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| Age, Customized | Number | Participants |
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| Sex/Gender, Customized | Number | participant |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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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 Montgomery-Asberg Depression Rating Scale (MADRS) | The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. | of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 54 for 1.5 to 3.0 mg Cariprazine | Posted | Mean | Standard Error | Score on scale | Baseline to Week 8 |
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| Secondary | Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I ) | The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse. | of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 53 for 1.5 to 3.0 mg Cariprazine | Posted | Mean | Standard Error | Score on Scale | Baseline to Week 8 |
|
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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 | Matching placebo capsules, orally administered for 8 weeks | 2 | 77 | 51 | 77 | ||
| EG001 | 0.25 to 0.75 mg Cariprazine | Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks | 2 | 75 | 48 | 75 | ||
| EG002 | 1.5 to 3.0 mg Cariprazine | 1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks | 2 | 75 | 52 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar I disorder | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Suicidal attempt | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MeDRA version 13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MeDRA version 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA version 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MeDRA version 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Weight Increase | Investigations | MeDRA version 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MeDRA version 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MeDRA version 13.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MeDRA version 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MeDRA version 13.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MeDRA version 13.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MeDRA version 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MeDRA version 13.0 | 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 | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan Sales LLC | 877-277-8566 | IR-CTRegistration@allergan.com |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| 20, 30 |
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| 30, 40 |
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| 40, 50 |
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| 50, 60 |
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| ≥ 60 |
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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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| Non-Caucasian |
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| Black |
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| Asian |
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| Other |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Superiority |
| Participants |
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