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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 and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cariprazine + ADT | Experimental | Cariprazine, flexible dose (titrated to a dose of 3.0 milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine | Drug | Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug. | First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks) |
| Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period. | 2 weeks following the 26-week Treatment Period |
| Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance. | Baseline (Week 0) to up to 26 weeks in the Treatment Period |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters | Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Willie Earley, MD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 032 | Tucson | Arizona | 85710 | United States | ||
| Forest Investigative Site 109 |
Rollover participants from Study RGH-MD-72 [NCT01715805] were eligible for this study if they had completed either the double-blind treatment or the continued-treatment periods. New patients were eligible if they had an ongoing inadequate response to a protocol-allowed antidepressant therapy (ADT).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cariprazine + ADT | Cariprazine, flexible dose (titrated to a dose of 3.0milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Antidepressant Therapy (ADT) | Drug | ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug |
|
| Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks) |
| Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) | A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report. | Baseline (Week 0) to up to 26 weeks |
| Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs | Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia. | First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks) |
| Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. | Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study |
| Number of Participants With Treatment-Emergent Ocular Events | A TEAE is an AE that occurs or worsens after receiving study drug. Ocular events are adverse events related to the eye. | First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks) |
| Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score | The ASEX is a participant-completed scale to evaluate overall sexual experiences over the previous 7 days consisting of 5 questions answered on a scale of 1 (best) to 6 (worst) for a total possible score of 3 to 30 (2 questions were only answered if the participant was sexually active in the past week), higher score indicates greater sexual dysfunction. There are different forms for males and females. A negative change from Baseline indicates improvement. | Baseline (Lead-in study Baseline for roll-over participants and prior to first dose of this study for new participants) to End of Treatment (Up to Week 26) in this study |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Forest Investigative Site 105 | Fayetteville | Arkansas | 72703 | United States |
| Forest Investigative Site 018 | Little Rock | Arkansas | 72211 | United States |
| Forest Investigative Site 029 | Little Rock | Arkansas | 72211 | United States |
| Forest Investigative Site 082 | Garden Grove | California | 92845 | United States |
| Forest Investigative Site 107 | Long Beach | California | 90822 | United States |
| Forest Investigative Site 104 | National City | California | 91950 | United States |
| Forest Investigative Site 022 | Newport Beach | California | 92660 | United States |
| Forest Investigative Site 004 | Oceanside | California | 92056 | United States |
| Forest Investigative Site 078 | Rancho Mirage | California | 92270 | United States |
| Forest Investigative Site 080 | Redlands | California | 92374 | United States |
| Forest Investigative Site 113 | San Diego | California | 92102 | United States |
| Forest Investigative Site 054 | San Diego | California | 92108 | United States |
| Forest Investigative Site 007 | San Diego | California | 92123 | United States |
| Forest Investigative Site 031 | Temecula | California | 92591 | United States |
| Forest Investigative Site 048 | Denver | Colorado | 80239 | United States |
| Forest Investigative Site 114 | Norwich | Connecticut | 06360 | United States |
| Forest Investigative Site 037 | Coral Springs | Florida | 33067 | United States |
| Forest Investigative Site 053 | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site 023 | Hallandale | Florida | 33009 | United States |
| Forest Investigative Site 071 | Hialeah | Florida | 33012 | United States |
| Forest Investigative Site 006 | Leesburg | Florida | 34748 | United States |
| Forest Investigative Site 112 | Maitland | Florida | 32751 | United States |
| Forest Investigative Site 026 | Miami | Florida | 33145 | United States |
| Forest Investigative Site 075 | Miami | Florida | 33165 | United States |
| Forest Investigative Site 027 | North Miami | Florida | 33161 | United States |
| Forest Investigative Site 074 | North Miami | Florida | 33161 | United States |
| Forest Investigative Site 036 | Oakland Park | Florida | 33334 | United States |
| Forest Investigative Site 051 | Orlando | Florida | 32803 | United States |
| Forest Investigative Site 044 | South Miami | Florida | 33143 | United States |
| Forest Investigative Site 008 | Tampa | Florida | 33613 | United States |
| Forest Investigative Site 019 | Winter Park | Florida | 32789 | United States |
| Forest Investigative Site 060 | Atlanta | Georgia | 30329 | United States |
| Forest Investigative Site 024 | Atlanta | Georgia | 30331 | United States |
| Forest Investigative Site 017 | Marietta | Georgia | 30060 | United States |
| Forest Investigative Site 047 | Smyrna | Georgia | 30080 | United States |
| Forest Investigative Site 070 | Chicago | Illinois | 60612 | United States |
| Forest Investigative Site 013 | Hoffman Estates | Illinois | 60169 | United States |
| Forest Investigative Site 063 | Libertyville | Illinois | 60048 | United States |
| Forest Investigative Site 062 | Maywood | Illinois | 60153 | United States |
| Forest Investigative Site 072 | Naperville | Illinois | 60563 | United States |
| Forest Investigative Site 010 | Oak Brook | Illinois | 60523 | United States |
| Forest Investigative Site 068 | Skokie | Illinois | 60076 | United States |
| Forest Investigative Site 061 | Indianapolis | Indiana | 46260 | United States |
| Forest Investigative Site 042 | Lafayette | Indiana | 47905 | United States |
| Forest Investigative Site 065 | Overland Park | Kansas | 66211 | United States |
| Forest Investigative Site 073 | New Orleans | Louisiana | 70115 | United States |
| Forest Investigative Site 049 | Gaithersburg | Maryland | 20877 | United States |
| Forest Investigative Site 077 | Rockville | Maryland | 20850 | United States |
| Forest Investigative Site 110 | Rockville | Maryland | 20852 | United States |
| Forest Investigative Site 046 | Boston | Massachusetts | 02131 | United States |
| Forest Investigative Site 045 | Natick | Massachusetts | 01760 | United States |
| Forest Investigative Site 103 | Saint Charles | Missouri | 63304 | United States |
| Forest Investigative Site 106 | Berlin | New Jersey | 08009 | United States |
| Forest Investigative Site 014 | Toms River | New Jersey | 08755 | United States |
| Forest Investigative Site 058 | Albuquerque | New Mexico | 87109 | United States |
| Forest Investigative Site 028 | Brooklyn | New York | 11214 | United States |
| Forest Investigative Site 016 | New York | New York | 10023 | United States |
| Forest Investigative Site 025 | Staten Island | New York | 10305 | United States |
| Forest Investigative Site 076 | The Bronx | New York | 10467 | United States |
| Forest Investigative Site 050 | Durham | North Carolina | 27710 | United States |
| Forest Investigative Site 067 | Bismarck | North Dakota | 58501 | United States |
| Forest Investigative Site 011 | Cincinnati | Ohio | 45219 | United States |
| Forest Investigative Site 015 | Cincinnati | Ohio | 45227 | United States |
| Forest Investigative Site 055 | Columbus | Ohio | 43210 | United States |
| Forest Investigative Site 066 | Mason | Ohio | 45040 | United States |
| Forest Investigative Site 064 | Middleburg Heights | Ohio | 44130 | United States |
| Forest Investigative Site 038 | Oklahoma City | Oklahoma | 72112 | United States |
| Forest Investigative Site 035 | Oklahoma City | Oklahoma | 73103 | United States |
| Forest Investigative Site 039 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 003 | Portland | Oregon | 97210 | United States |
| Forest Investigative Site 052 | Allentown | Pennsylvania | 18104 | United States |
| Forest Investigative Site 102 | Norristown | Pennsylvania | 19403 | United States |
| Forest Investigative Site 059 | Lincoln | Rhode Island | 02865 | United States |
| Forest Investigative Site 001 | Charleston | South Carolina | 29425 | United States |
| Forest Investigative Site 079 | Austin | Texas | 78732 | United States |
| Forest Investigative Site 005 | Houston | Texas | 77008 | United States |
| Forest Investigative Site 108 | The Woodlands | Texas | 77381 | United States |
| Forest Investigative Site 069 | Wichita Falls | Texas | 76309 | United States |
| Forest Investigative Site 111 | Murray | Utah | 84123 | United States |
| Forest Investigative Site 041 | Charlottesville | Virginia | 22903 | United States |
| Forest Investigative Site 081 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 100 | Bothell | Washington | 98011 | United States |
| Forest Investigative Site 043 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site 101 | Middleton | Wisconsin | 53562 | United States |
| Forest Investigative Site 056 | Milwaukee | Wisconsin | 53227 | United States |
| Forest Investigative Site 057 | Waukesha | Wisconsin | 53188 | United States |
| Forest Investigative Site 033 | San Juan | 00918 | Puerto Rico |
| Forest Investigative Site 034 | San Juan | 00927 | Puerto Rico |
| Safety Population; Received Study Drug |
|
| Entered Safety Follow-up Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cariprazine + ADT | Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug. | Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study. | Posted | Count of Participants | Participants | First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period. | Participants in the Safety Population, all participants in the enrolled population who took at least 1 dose of cariprazine in this study, who entered the Safety Follow-up period. | Posted | Count of Participants | Participants | 2 weeks following the 26-week Treatment Period |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance. | Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study. | Posted | Count of Participants | Participants | Baseline (Week 0) to up to 26 weeks in the Treatment Period |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters | Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance. | Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study. | Posted | Count of Participants | Participants | Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) | A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report. | Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study. | Posted | Count of Participants | Participants | Baseline (Week 0) to up to 26 weeks |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs | Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia. | Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study. | Posted | Count of Participants | Participants | First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. | Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study. | Posted | Number | participants | Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Ocular Events | A TEAE is an AE that occurs or worsens after receiving study drug. Ocular events are adverse events related to the eye. | Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study. | Posted | Count of Participants | Participants | First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks) |
|
| |||||||||||||||||||||||||||
| Primary | Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score | The ASEX is a participant-completed scale to evaluate overall sexual experiences over the previous 7 days consisting of 5 questions answered on a scale of 1 (best) to 6 (worst) for a total possible score of 3 to 30 (2 questions were only answered if the participant was sexually active in the past week), higher score indicates greater sexual dysfunction. There are different forms for males and females. A negative change from Baseline indicates improvement. | Participants from the Safety Population, all participants in the enrolled population who took at least 1 dose of cariprazine in this study, with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Lead-in study Baseline for roll-over participants and prior to first dose of this study for new participants) to End of Treatment (Up to Week 26) in this study |
|
First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
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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 | Cariprazine + ADT | Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks. | 2 | 345 | 7 | 345 | 274 | 345 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C533287 | cariprazine |
Not provided
Not provided
Not provided
| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
|
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| Participants |
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