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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000803-25 | EudraCT Number |
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1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Cariprazine 3.0 mg/day | Experimental | Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks. |
|
| Double-Blind Cariprazine 1.5 mg/day | Experimental | Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks. |
|
| Double-Blind Placebo | Placebo Comparator | Participants randomized to receive placebo QD for up to 39 weeks. |
|
| Open Label Treatment | Experimental | Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine | Drug | Cariprazine capsules, oral administration, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period | Relapse was defined as the occurrence of any 1 of the following:
Time to first relapse (days) was calculated as the date of the first relapse - the date of randomization + 1. Participants who did not meet the relapse criteria were considered censored at the time of completion or discontinuation from the Double-Blind Treatment Period (DBTP) of the study. Percentiles (95% Confidence Intervals [CI]) are based on Kaplan-Meier estimates. | From Week 16 to Week 55 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group /ID# 232932 | Little Rock | Arkansas | 72211 | United States | ||
| Woodland Research Northwest, LLC /ID# 232982 |
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| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
A total of 901 participants were enrolled; 5 participants did not enter the open label treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Treatment Period | Participants started on cariprazine 1.5 mg once daily (QD), with a target dose of 3.0 mg QD, for up to 16 weeks. |
| FG001 | Double-Blind Placebo QD | Partcipants randomized to receive placebo QD for up to 39 weeks. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Open Label Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2022 | Aug 28, 2023 |
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| Placebo | Drug | Matching placebo capsules, oral administration, once daily |
|
| Rogers |
| Arkansas |
| 72758-6442 |
| United States |
| California Pharmaceutical Research Institute Inc. /ID# 232745 | Anaheim | California | 92804 | United States |
| Advanced Research Center /ID# 233120 | Anaheim | California | 92805 | United States |
| CI Trials /ID# 232642 | Bellflower | California | 90706-7079 | United States |
| Synexus Clinical Research US Inc. /ID# 232743 | Cerritos | California | 90703 | United States |
| ATP Clinical Research, Inc /ID# 232979 | Costa Mesa | California | 92626-4607 | United States |
| ProScience Research Group /ID# 232945 | Culver City | California | 90230-6632 | United States |
| Collaborative Neuroscience Research - Orange County /ID# 233077 | Garden Grove | California | 92845 | United States |
| Behavioral Research Specialists, LLC /ID# 232980 | Glendale | California | 91206-4261 | United States |
| Omega Clinical Trials LLC /ID# 233150 | La Habra | California | 90631-3842 | United States |
| Synergy San Diego /ID# 232740 | Lemon Grove | California | 91945-2956 | United States |
| Alliance for Research - Long Beach /ID# 232926 | Long Beach | California | 90807 | United States |
| NRC Research Institute /ID# 232741 | Orange | California | 92868 | United States |
| CNRI-San Diego /ID# 232748 | San Diego | California | 92102 | United States |
| Artemis Institute for Clinical Research /ID# 233151 | San Marcos | California | 92078-2338 | United States |
| Artemis Institute for Clinical Research /ID# 233152 | San Marcos | California | 92078-2338 | United States |
| Collaborative Neuroscience Research LLC /ID# 232750 | Torrance | California | 90502 | United States |
| Duplicate_MCB Clinical Research Centers LLC /ID# 232838 | Colorado Springs | Colorado | 80910 | United States |
| Velocity Clinical Research - Hallandale Beach /ID# 232647 | Hallandale | Florida | 33009-4427 | United States |
| Research Centers of America - Hollywood FL /ID# 232649 | Hollywood | Florida | 33024-2706 | United States |
| CNS Healthcare - Jacksonville /ID# 233160 | Jacksonville | Florida | 32256-6039 | United States |
| Meridien Research /ID# 232941 | Maitland | Florida | 32751 | United States |
| Miami Lakes Medical Research /ID# 232826 | Miami Lakes | Florida | 33016 | United States |
| University of South Florida /ID# 233093 | Tampa | Florida | 33612 | United States |
| Synexus Clinical Research, Inc /ID# 232950 | Atlanta | Georgia | 30328 | United States |
| Atlanta Center for Medical Research /ID# 232832 | Atlanta | Georgia | 30331 | United States |
| CenExcel iResearch LLC /ID# 233045 | Decatur | Georgia | 30030 | United States |
| Atlanta Behavioral Research, LLC /ID# 232935 | Dunwoody | Georgia | 30338 | United States |
| NeuroPsychiatric Research Practice & Associate LTD /ID# 232840 | Winfield | Illinois | 60190 | United States |
| Louisiana Clinical Research /ID# 232685 | Shreveport | Louisiana | 71101 | United States |
| CBH Health LLC /ID# 232699 | Gaithersburg | Maryland | 20877 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709 | Saint Charles | Missouri | 63304 | United States |
| Duplicate_Altea Research Institute /ID# 232784 | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute /ID# 233088 | Berlin | New Jersey | 08009 | United States |
| Neurobehavioral Research Inc /ID# 232791 | Cedarhurst | New York | 11516 | United States |
| New Hope Clinical Research Inc. /ID# 232716 | Charlotte | North Carolina | 28211 | United States |
| Richard Weisler MD, PA & Assoc /ID# 233049 | Raleigh | North Carolina | 27609 | United States |
| Clinical Inquest Center Ltd /ID# 233043 | Beavercreek | Ohio | 45431-2573 | United States |
| DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739 | Columbus | Ohio | 43210 | United States |
| Midwest Clinical Research Center /ID# 232737 | Dayton | Ohio | 45417 | United States |
| Sooner Clinical Research /ID# 232931 | Oklahoma City | Oklahoma | 73112 | United States |
| Community Clinical Research Inc. /ID# 232672 | Austin | Texas | 78754 | United States |
| Pillar Clinical Research LLC /ID# 232667 | Richardson | Texas | 75080 | United States |
| Pillar Clinical Research LLC /ID# 232673 | Richardson | Texas | 75080 | United States |
| Family Psychiatry of The Woodlands /ID# 232943 | The Woodlands | Texas | 77381 | United States |
| Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777 | Burgas | 8001 | Bulgaria |
| State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 232779 | Kardzhali | 6600 | Bulgaria |
| MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 232893 | Kazanlak | 6100 | Bulgaria |
| State Psychiatric Hospital - Lovech /ID# 232771 | Lovech | 5500 | Bulgaria |
| Second Psychiatric Clinic for General Psychiatry and Addictions of UMHAT Dr. Geo /ID# 232773 | Pleven | 5800 | Bulgaria |
| UMHAT Dr Georgi Stranski EAD /ID# 233105 | Pleven | 5800 | Bulgaria |
| UMHAT Kanev /ID# 233101 | Rousse | 7002 | Bulgaria |
| Clinic of Child Psychiatry St Nicolas /ID# 232925 | Sofia | 1431 | Bulgaria |
| MHAT Targovishte /ID# 232942 | Targovishte | 7700 | Bulgaria |
| Hospital Raja Permaisuri Bainun /ID# 233114 | Ipoh | Perak | 30450 | Malaysia |
| University Malaya Med Ctr /ID# 233108 | Kuala Lumpur | 59100 | Malaysia |
| Specjalistyczny Gabinet Lekarski /ID# 232702 | Lublin | Lublin Voivodeship | 20-582 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 232848 | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170 | Poznan | Silesian Voivodeship | 60-744 | Poland |
| Poradnia Zdrowia Psychicznego /ID# 232878 | Chełmno | 86-200 | Poland |
| INSPIRA Clinical Research /ID# 232704 | San Juan | 00918 | Puerto Rico |
| Kazan State Medical University /ID# 233110 | Kazan' | Tatarstan, Respublika | 420012 | Russia |
| Mental Health Research Centre /ID# 232864 | Moscow | 115522 | Russia |
| Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 232946 | Nizhny Novgorod | 603155 | Russia |
| Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933 | Orenburg | 460006 | Russia |
| State Public Institution of Healthcare Leningrad Regional Psychoneurology Dispen /ID# 232872 | Roschino | 188820 | Russia |
| St. Nicolas Psychiatric Hospital /ID# 232858 | Saint Petersburg | 190121 | Russia |
| St. Nicolas Psychiatric Hospital /ID# 232859 | Saint Petersburg | 190121 | Russia |
| National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232927 | Saint Petersburg | 192019 | Russia |
| National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232928 | Saint Petersburg | 192019 | Russia |
| I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 232930 | Saint Petersburg | 197341 | Russia |
| Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 232936 | Saratov | 410028 | Russia |
| Regional Clinical Psychiatry Hospital /ID# 232856 | Saratov | 410060 | Russia |
| Ltd Clinic Hundred Years /ID# 232866 | Tomsk | 634009 | Russia |
| Region Specialized Psychiatric Hospital #2 /ID# 232850 | Tonnelniy | 357034 | Russia |
| University Clinical Center Serbia /ID# 233095 | Belgrade | Beograd | 11000 | Serbia |
| University Clinical Center Kragujevac /ID# 233096 | Kragujevac | Sumadijski Okrug | 34000 | Serbia |
| Clinical Center Vojvodina /ID# 233038 | Novi Sad | Vojvodina | 21000 | Serbia |
| Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 232641 | Belgrade | 11040 | Serbia |
| Institute of Mental Health /ID# 232958 | Belgrade | 11108 | Serbia |
| Special Hospital for Psychiatric Diseases Kovin /ID# 232829 | Kovin | 26220 | Serbia |
| Clinical Centre Kragujevac /ID# 232874 | Kragujevac | 34000 | Serbia |
| Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846 | Novi Kneževac | 23330 | Serbia |
| Inje University Busan Paik Hospital /ID# 233097 | Busan | 47392 | South Korea |
| Inje University Haeundae Hospital /ID# 233141 | Busan | 48108 | South Korea |
| Chonnam National University Hospital /ID# 233098 | Gwangju | 61469 | South Korea |
| Jeju National University Hospital /ID# 233104 | Jeju City | 63238 | South Korea |
| Duplicate_Chonbuk National University Hospital /ID# 232654 | Jeonju | 54907 | South Korea |
| Taipei Veterans General Hospital /ID# 232947 | Taipei City | Taipei | 11217 | Taiwan |
| Taipei Tzu Chi Hospital /ID# 233128 | New Taipei City | 23142 | Taiwan |
| China Medical University Hospital /ID# 233091 | Taichung | 40447 | Taiwan |
| National Cheng Kung University Hospital /ID# 233109 | Tainan | 704 | Taiwan |
| Tri-Service General Hospital /ID# 233078 | Taipei | 11490 | Taiwan |
| Maharaj Nakorn Chiang Mai Hospital /ID# 232860 | Chiang Mai | 50200 | Thailand |
| Suan Prung Psychiatric Hospital /ID# 232862 | Muang | 50100 | Thailand |
| Cherkasy regional psychiatric hospital of the CRC /ID# 232686 | Smila | Cherkasy Oblast | 20708 | Ukraine |
| Geikivka multidisciplinary hospital for psychiatric care /ID# 232678 | Kryvbas Village | Dnipropetrovsk Oblast | 53054 | Ukraine |
| SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232937 | Kharkiv | Kharkiv Oblast | 61068 | Ukraine |
| SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232938 | Kharkiv | Kharkiv Oblast | 61068 | Ukraine |
| SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232939 | Kharkiv | Kharkiv Oblast | 61068 | Ukraine |
| Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684 | Stepanivka Village | Kherson Oblast | 73488 | Ukraine |
| Odesa regional psychiatric hospital 2 of the ORC /ID# 232682 | Oleksandrivka Village | Odesa Oblast | 67513 | Ukraine |
| KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 232680 | Uzhhorod | Zakarpattia Oblast | 88000 | Ukraine |
| Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric /ID# 232876 | Lviv | 79021 | Ukraine |
| MNCE Odesa Regional Medical Center for Mental Health /ID# 232944 | Odesa | 65006 | Ukraine |
| CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU /ID# 232853 | Vinnytsia | 21005 | Ukraine |
| Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852 | Vinnytsia | 21005 | Ukraine |
| FG002 | Double-Blind Cariprazine 1.5 mg QD | Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks. |
| FG003 | Double-Blind Cariprazine 3.0 mg QD | Participants randomized to receive cariprazine 3.0 mg QD for up to 39 weeks. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind Treatment Period |
|
|
Safety Population: all participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Treatment Period | Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | 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 | Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period | Relapse was defined as the occurrence of any 1 of the following:
Time to first relapse (days) was calculated as the date of the first relapse - the date of randomization + 1. Participants who did not meet the relapse criteria were considered censored at the time of completion or discontinuation from the Double-Blind Treatment Period (DBTP) of the study. Percentiles (95% Confidence Intervals [CI]) are based on Kaplan-Meier estimates. | Double-Blind Intent-to-Treat Population: All participants who took at least 1 dose of DB IP and had at least 1 post-randomization assessment of the YMRS, MADRS or CGI-S scores or relapsed during the 39-week DBTP of the study. | Posted | Median | 95% Confidence Interval | days | From Week 16 to Week 55 |
|
|
|
|
Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).
ACM data include all enrolled (Open Label Treatment Period) or randomized (Double Blind Treatment Period) participants; AE data include all participants who were treated (Open Label Treatment Period) or randomized and treated (Double Blind Treatment Period).
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 | Open Label Treatment Period | Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks. | 1 | 901 | 19 | 896 | 256 | 896 |
| EG001 | Double-Blind Placebo QD | Participants randomized to receive placebo QD for up to 39 weeks. | 1 | 145 | 5 | 145 | 27 | 145 |
| EG002 | Double-Blind Cariprazine 1.5 mg QD | Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks. | 0 | 147 | 7 | 144 | 34 | 144 |
| EG003 | Double-Blind Cariprazine 3.0 mg QD | Participants randomized to receive cariprazine 3.0 mg QD for up to 39 weeks. | 0 | 148 | 3 | 147 | 34 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PALPITATIONS | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| APPENDICEAL ABSCESS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| CORONAVIRUS PNEUMONIA | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SACRAL RADICULOPATHY | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| BIPOLAR I DISORDER | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HALLUCINATION, AUDITORY | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| STEVENS-JOHNSON SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| AKATHISIA | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2022 | Aug 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000087122 | Mania |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C533287 | cariprazine |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Non-Compliance With Study Drug |
|
| Other, Not Specified |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 50% percentile |
|
| 75% percentile |
|
| Log Rank | 0.6308 | P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US). | Hazard Ratio (HR) | 0.89 | 2-Sided | 95 | 0.52 | 1.51 | Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US). | Superiority |