A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

NCT03573297 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: RGH-MD-252017-000803-25
• Study Type: interventional
• Target: 901
• Locations: 11 countries
• Sites: 108

Brief Summary

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

Conditions

Bipolar I Disorder; Mania; Depression

Outcome Measures

Primary Outcomes (1)

• 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: * Young Mania Rating Score (YMRS) total score ≥ 17 (range 0-60; higher score indicates a worse outcome); * Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20 (range 0-60; higher score indicates more depressive symptoms); * Clinical Global Impression-Improvement scale (CGI-S) ≥ 4 (range from 1 \[normal, not at all ill\] to 7 \[extremely ill\]); * Initiation of additional psychiatric medication; * Psychiatric hospitalization; * Exacerbation of illness as judged by clinical impression of the Investigator. 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

Study Arms (4)

Double-Blind Cariprazine 3.0 mg/day

EXPERIMENTAL

Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.

Drug: Cariprazine

Double-Blind Cariprazine 1.5 mg/day

EXPERIMENTAL

Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.

Drug: Cariprazine

Double-Blind Placebo

PLACEBO COMPARATOR

Participants randomized to receive placebo QD for up to 39 weeks.

Drug: Placebo

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.

Drug: Cariprazine

Interventions

Cariprazine DRUG

Cariprazine capsules, oral administration, once daily

Double-Blind Cariprazine 1.5 mg/day; Double-Blind Cariprazine 3.0 mg/day; Open Label Treatment

Placebo DRUG

Matching placebo capsules, oral administration, once daily

Double-Blind Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
• Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
• OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).

You may not qualify if:

• Four or more episodes of a mood disturbance within the 12 months before Visit 1;
• Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (108)

Woodland International Research Group /ID# 232932

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest, LLC /ID# 232982

Rogers, Arkansas, 72758-6442, United States

Location

California Pharmaceutical Research Institute Inc. /ID# 232745

Anaheim, California, 92804, United States

Location

Advanced Research Center /ID# 233120

Anaheim, California, 92805, United States

Location

CI Trials /ID# 232642

Bellflower, California, 90706-7079, United States

Location

Synexus Clinical Research US Inc. /ID# 232743

Cerritos, California, 90703, United States

Location

ATP Clinical Research, Inc /ID# 232979

Costa Mesa, California, 92626-4607, United States

Location

ProScience Research Group /ID# 232945

Culver City, California, 90230-6632, United States

Location

Collaborative Neuroscience Research - Orange County /ID# 233077

Garden Grove, California, 92845, United States

Location

Behavioral Research Specialists, LLC /ID# 232980

Glendale, California, 91206-4261, United States

Location

Omega Clinical Trials LLC /ID# 233150

La Habra, California, 90631-3842, United States

Location

Synergy San Diego /ID# 232740

Lemon Grove, California, 91945-2956, United States

Location

Alliance for Research - Long Beach /ID# 232926

Long Beach, California, 90807, United States

Location

NRC Research Institute /ID# 232741

Orange, California, 92868, United States

Location

CNRI-San Diego /ID# 232748

San Diego, California, 92102, United States

Location

Artemis Institute for Clinical Research /ID# 233151

San Marcos, California, 92078-2338, United States

Location

Artemis Institute for Clinical Research /ID# 233152

San Marcos, California, 92078-2338, United States

Location

Collaborative Neuroscience Research LLC /ID# 232750

Torrance, California, 90502, United States

Location

Duplicate_MCB Clinical Research Centers LLC /ID# 232838

Colorado Springs, Colorado, 80910, United States

Location

Velocity Clinical Research - Hallandale Beach /ID# 232647

Hallandale, Florida, 33009-4427, United States

Location

Research Centers of America - Hollywood FL /ID# 232649

Hollywood, Florida, 33024-2706, United States

Location

CNS Healthcare - Jacksonville /ID# 233160

Jacksonville, Florida, 32256-6039, United States

Location

Meridien Research /ID# 232941

Maitland, Florida, 32751, United States

Location

Miami Lakes Medical Research /ID# 232826

Miami Lakes, Florida, 33016, United States

Location

University of South Florida /ID# 233093

Tampa, Florida, 33612, United States

Location

Synexus Clinical Research, Inc /ID# 232950

Atlanta, Georgia, 30328, United States

Location

Atlanta Center for Medical Research /ID# 232832

Atlanta, Georgia, 30331, United States

Location

CenExcel iResearch LLC /ID# 233045

Decatur, Georgia, 30030, United States

Location

Atlanta Behavioral Research, LLC /ID# 232935

Dunwoody, Georgia, 30338, United States

Location

NeuroPsychiatric Research Practice & Associate LTD /ID# 232840

Winfield, Illinois, 60190, United States

Location

Louisiana Clinical Research /ID# 232685

Shreveport, Louisiana, 71101, United States

Location

CBH Health LLC /ID# 232699

Gaithersburg, Maryland, 20877, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709

Saint Charles, Missouri, 63304, United States

Location

Duplicate_Altea Research Institute /ID# 232784

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute /ID# 233088

Berlin, New Jersey, 08009, United States

Location

Neurobehavioral Research Inc /ID# 232791

Cedarhurst, New York, 11516, United States

Location

New Hope Clinical Research Inc. /ID# 232716

Charlotte, North Carolina, 28211, United States

Location

Richard Weisler MD, PA & Assoc /ID# 233049

Raleigh, North Carolina, 27609, United States

Location

Clinical Inquest Center Ltd /ID# 233043

Beavercreek, Ohio, 45431-2573, United States

Location

DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739

Columbus, Ohio, 43210, United States

Location

Midwest Clinical Research Center /ID# 232737

Dayton, Ohio, 45417, United States

Location

Sooner Clinical Research /ID# 232931

Oklahoma City, Oklahoma, 73112, United States

Location

Community Clinical Research Inc. /ID# 232672

Austin, Texas, 78754, United States

Location

Pillar Clinical Research LLC /ID# 232667

Richardson, Texas, 75080, United States

Location

Pillar Clinical Research LLC /ID# 232673

Richardson, Texas, 75080, United States

Location

Family Psychiatry of The Woodlands /ID# 232943

The Woodlands, Texas, 77381, United States

Location

Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777

Burgas, 8001, Bulgaria

Location

State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 232779

Kardzhali, 6600, Bulgaria

Location

MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 232893

Kazanlak, 6100, Bulgaria

Location

State Psychiatric Hospital - Lovech /ID# 232771

Lovech, 5500, Bulgaria

Location

Second Psychiatric Clinic for General Psychiatry and Addictions of UMHAT Dr. Geo /ID# 232773

Pleven, 5800, Bulgaria

Location

UMHAT Dr Georgi Stranski EAD /ID# 233105

Pleven, 5800, Bulgaria

Location

UMHAT Kanev /ID# 233101

Rousse, 7002, Bulgaria

Location

Clinic of Child Psychiatry St Nicolas /ID# 232925

Sofia, 1431, Bulgaria

Location

MHAT Targovishte /ID# 232942

Targovishte, 7700, Bulgaria

Location

Hospital Raja Permaisuri Bainun /ID# 233114

Ipoh, Perak, 30450, Malaysia

Location

University Malaya Med Ctr /ID# 233108

Kuala Lumpur, 59100, Malaysia

Location

Specjalistyczny Gabinet Lekarski /ID# 232702

Lublin, Lublin Voivodeship, 20-582, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 232848

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170

Poznan, Silesian Voivodeship, 60-744, Poland

Location

Poradnia Zdrowia Psychicznego /ID# 232878

Chełmno, 86-200, Poland

Location

INSPIRA Clinical Research /ID# 232704

San Juan, 00918, Puerto Rico

Location

Kazan State Medical University /ID# 233110

Kazan', Tatarstan, Respublika, 420012, Russia

Location

Mental Health Research Centre /ID# 232864

Moscow, 115522, Russia

Location

Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 232946

Nizhny Novgorod, 603155, Russia

Location

Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933

Orenburg, 460006, Russia

Location

State Public Institution of Healthcare Leningrad Regional Psychoneurology Dispen /ID# 232872

Roschino, 188820, Russia

Location

St. Nicolas Psychiatric Hospital /ID# 232858

Saint Petersburg, 190121, Russia

Location

St. Nicolas Psychiatric Hospital /ID# 232859

Saint Petersburg, 190121, Russia

Location

National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232927

Saint Petersburg, 192019, Russia

Location

National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232928

Saint Petersburg, 192019, Russia

Location

I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 232930

Saint Petersburg, 197341, Russia

Location

Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 232936

Saratov, 410028, Russia

Location

Regional Clinical Psychiatry Hospital /ID# 232856

Saratov, 410060, Russia

Location

Ltd Clinic Hundred Years /ID# 232866

Tomsk, 634009, Russia

Location

Region Specialized Psychiatric Hospital #2 /ID# 232850

Tonnelniy, 357034, Russia

Location

University Clinical Center Serbia /ID# 233095

Belgrade, Beograd, 11000, Serbia

Location

University Clinical Center Kragujevac /ID# 233096

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

Clinical Center Vojvodina /ID# 233038

Novi Sad, Vojvodina, 21000, Serbia

Location

Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 232641

Belgrade, 11040, Serbia

Location

Institute of Mental Health /ID# 232958

Belgrade, 11108, Serbia

Location

Special Hospital for Psychiatric Diseases Kovin /ID# 232829

Kovin, 26220, Serbia

Location

Clinical Centre Kragujevac /ID# 232874

Kragujevac, 34000, Serbia

Location

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846

Novi Kneževac, 23330, Serbia

Location

Inje University Busan Paik Hospital /ID# 233097

Busan, 47392, South Korea

Location

Inje University Haeundae Hospital /ID# 233141

Busan, 48108, South Korea

Location

Chonnam National University Hospital /ID# 233098

Gwangju, 61469, South Korea

Location

Jeju National University Hospital /ID# 233104

Jeju City, 63238, South Korea

Location

Duplicate_Chonbuk National University Hospital /ID# 232654

Jeonju, 54907, South Korea

Location

Taipei Veterans General Hospital /ID# 232947

Taipei City, Taipei, 11217, Taiwan

Location

Taipei Tzu Chi Hospital /ID# 233128

New Taipei City, 23142, Taiwan

Location

China Medical University Hospital /ID# 233091

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital /ID# 233109

Tainan, 704, Taiwan

Location

Tri-Service General Hospital /ID# 233078

Taipei, 11490, Taiwan

Location

Maharaj Nakorn Chiang Mai Hospital /ID# 232860

Chiang Mai, 50200, Thailand

Location

Suan Prung Psychiatric Hospital /ID# 232862

Muang, 50100, Thailand

Location

Cherkasy regional psychiatric hospital of the CRC /ID# 232686

Smila, Cherkasy Oblast, 20708, Ukraine

Location

Geikivka multidisciplinary hospital for psychiatric care /ID# 232678

Kryvbas Village, Dnipropetrovsk Oblast, 53054, Ukraine

Location

SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232937

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232938

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232939

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684

Stepanivka Village, Kherson Oblast, 73488, Ukraine

Location

Odesa regional psychiatric hospital 2 of the ORC /ID# 232682

Oleksandrivka Village, Odesa Oblast, 67513, Ukraine

Location

KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 232680

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

Location

Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric /ID# 232876

Lviv, 79021, Ukraine

Location

MNCE Odesa Regional Medical Center for Mental Health /ID# 232944

Odesa, 65006, Ukraine

Location

CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU /ID# 232853

Vinnytsia, 21005, Ukraine

Location

Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852

Vinnytsia, 21005, Ukraine

Location

Related Links

• Related Info

MeSH Terms

Conditions

Mania; Depression

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 29, 2018
• Study Start: June 15, 2018
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: 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/

Locations

US (46); PL (4); PR (1); KR (5); UA (12); RU (14); SE (8); MY (2); BU (9); TH (2); TW (5)