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Bipolar I DisorderPhase 3NCT03573297

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

A Phase 3 study testing Cariprazine in people with Bipolar I Disorder and Mania, run by AbbVie at 108 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar I Disorder, Mania, Depression
What is being tested?
Cariprazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
901 participants
Where
108 sitesin 11 countries
Study dates
15 Jun 2018to 5 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

108 sites in 11 countries.

108 sites in 11 countries

United States46 sites

  • California Pharmaceutical Research Institute Inc. /ID# 232745

    Anaheim, California, 92804

  • Advanced Research Center /ID# 233120

    Anaheim, California, 92805

  • Synexus Clinical Research, Inc /ID# 232950

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research /ID# 232832

    Atlanta, Georgia, 30331

  • Community Clinical Research Inc. /ID# 232672

    Austin, Texas, 78754

  • Clinical Inquest Center Ltd /ID# 233043

    Beavercreek, Ohio, 45431-2573

  • CI Trials /ID# 232642

    Bellflower, California, 90706-7079

  • Hassman Research Institute /ID# 233088

    Berlin, New Jersey, 08009

  • Neurobehavioral Research Inc /ID# 232791

    Cedarhurst, New York, 11516

  • Synexus Clinical Research US Inc. /ID# 232743

    Cerritos, California, 90703

  • New Hope Clinical Research Inc. /ID# 232716

    Charlotte, North Carolina, 28211

  • Duplicate_MCB Clinical Research Centers LLC /ID# 232838

    Colorado Springs, Colorado, 80910

  • DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739

    Columbus, Ohio, 43210

  • ATP Clinical Research, Inc /ID# 232979

    Costa Mesa, California, 92626-4607

  • ProScience Research Group /ID# 232945

    Culver City, California, 90230-6632

  • Midwest Clinical Research Center /ID# 232737

    Dayton, Ohio, 45417

  • CenExcel iResearch LLC /ID# 233045

    Decatur, Georgia, 30030

  • Atlanta Behavioral Research, LLC /ID# 232935

    Dunwoody, Georgia, 30338

  • CBH Health LLC /ID# 232699

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Research - Orange County /ID# 233077

    Garden Grove, California, 92845

  • Behavioral Research Specialists, LLC /ID# 232980

    Glendale, California, 91206-4261

  • Velocity Clinical Research - Hallandale Beach /ID# 232647

    Hallandale, Florida, 33009-4427

  • Research Centers of America - Hollywood FL /ID# 232649

    Hollywood, Florida, 33024-2706

  • CNS Healthcare - Jacksonville /ID# 233160

    Jacksonville, Florida, 32256-6039

  • Omega Clinical Trials LLC /ID# 233150

    La Habra, California, 90631-3842

  • Duplicate_Altea Research Institute /ID# 232784

    Las Vegas, Nevada, 89102

  • Synergy San Diego /ID# 232740

    Lemon Grove, California, 91945-2956

  • Woodland International Research Group /ID# 232932

    Little Rock, Arkansas, 72211

  • Alliance for Research - Long Beach /ID# 232926

    Long Beach, California, 90807

  • Meridien Research /ID# 232941

    Maitland, Florida, 32751

  • Miami Lakes Medical Research /ID# 232826

    Miami Lakes, Florida, 33016

  • Sooner Clinical Research /ID# 232931

    Oklahoma City, Oklahoma, 73112

  • NRC Research Institute /ID# 232741

    Orange, California, 92868

  • Richard Weisler MD, PA & Assoc /ID# 233049

    Raleigh, North Carolina, 27609

  • Pillar Clinical Research LLC /ID# 232667

    Richardson, Texas, 75080

  • Pillar Clinical Research LLC /ID# 232673

    Richardson, Texas, 75080

  • Woodland Research Northwest, LLC /ID# 232982

    Rogers, Arkansas, 72758-6442

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

    Saint Charles, Missouri, 63304

  • CNRI-San Diego /ID# 232748

    San Diego, California, 92102

  • Artemis Institute for Clinical Research /ID# 233151

    San Marcos, California, 92078-2338

  • Artemis Institute for Clinical Research /ID# 233152

    San Marcos, California, 92078-2338

  • Louisiana Clinical Research /ID# 232685

    Shreveport, Louisiana, 71101

  • University of South Florida /ID# 233093

    Tampa, Florida, 33612

  • Family Psychiatry of The Woodlands /ID# 232943

    The Woodlands, Texas, 77381

  • Collaborative Neuroscience Research LLC /ID# 232750

    Torrance, California, 90502

  • NeuroPsychiatric Research Practice & Associate LTD /ID# 232840

    Winfield, Illinois, 60190

Other trials in United States

Russia14 sites

  • Kazan State Medical University /ID# 233110

    Kazan', Tatarstan, Respublika, 420012

  • Mental Health Research Centre /ID# 232864

    Moscow, 115522

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

    Nizhny Novgorod, 603155

  • Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933

    Orenburg, 460006

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

    Roschino, 188820

  • St. Nicolas Psychiatric Hospital /ID# 232858

    Saint Petersburg, 190121

  • St. Nicolas Psychiatric Hospital /ID# 232859

    Saint Petersburg, 190121

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

    Saint Petersburg, 192019

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

    Saint Petersburg, 192019

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

    Saint Petersburg, 197341

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

    Saratov, 410028

  • Regional Clinical Psychiatry Hospital /ID# 232856

    Saratov, 410060

  • Ltd Clinic Hundred Years /ID# 232866

    Tomsk, 634009

  • Region Specialized Psychiatric Hospital #2 /ID# 232850

    Tonnelniy, 357034

Other trials in Russia

Ukraine12 sites

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

    Kharkiv, Kharkiv Oblast, 61068

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

    Kharkiv, Kharkiv Oblast, 61068

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

    Kharkiv, Kharkiv Oblast, 61068

  • Geikivka multidisciplinary hospital for psychiatric care /ID# 232678

    Kryvbas Village, Dnipropetrovsk Oblast, 53054

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

    Lviv, 79021

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

    Odesa, 65006

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

    Oleksandrivka Village, Odesa Oblast, 67513

  • Cherkasy regional psychiatric hospital of the CRC /ID# 232686

    Smila, Cherkasy Oblast, 20708

  • Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684

    Stepanivka Village, Kherson Oblast, 73488

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

    Uzhhorod, Zakarpattia Oblast, 88000

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

    Vinnytsia, 21005

  • Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852

    Vinnytsia, 21005

Other trials in Ukraine

Bulgaria9 sites

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

    Burgas, 8001

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

    Kardzhali, 6600

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

    Kazanlak, 6100

  • State Psychiatric Hospital - Lovech /ID# 232771

    Lovech, 5500

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

    Pleven, 5800

  • UMHAT Dr Georgi Stranski EAD /ID# 233105

    Pleven, 5800

  • UMHAT Kanev /ID# 233101

    Rousse, 7002

  • Clinic of Child Psychiatry St Nicolas /ID# 232925

    Sofia, 1431

  • MHAT Targovishte /ID# 232942

    Targovishte, 7700

Other trials in Bulgaria

Serbia8 sites

  • University Clinical Center Serbia /ID# 233095

    Belgrade, Beograd, 11000

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

    Belgrade, 11040

  • Institute of Mental Health /ID# 232958

    Belgrade, 11108

  • Special Hospital for Psychiatric Diseases Kovin /ID# 232829

    Kovin, 26220

  • University Clinical Center Kragujevac /ID# 233096

    Kragujevac, Sumadijski Okrug, 34000

  • Clinical Centre Kragujevac /ID# 232874

    Kragujevac, 34000

  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846

    Novi Kneževac, 23330

  • Clinical Center Vojvodina /ID# 233038

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Korea5 sites

  • Inje University Busan Paik Hospital /ID# 233097

    Busan, 47392

  • Inje University Haeundae Hospital /ID# 233141

    Busan, 48108

  • Chonnam National University Hospital /ID# 233098

    Gwangju, 61469

  • Jeju National University Hospital /ID# 233104

    Jeju City, 63238

  • Duplicate_Chonbuk National University Hospital /ID# 232654

    Jeonju, 54907

Other trials in South Korea

Taiwan5 sites

  • Taipei Tzu Chi Hospital /ID# 233128

    New Taipei City, 23142

  • China Medical University Hospital /ID# 233091

    Taichung, 40447

  • National Cheng Kung University Hospital /ID# 233109

    Tainan, 704

  • Tri-Service General Hospital /ID# 233078

    Taipei, 11490

  • Taipei Veterans General Hospital /ID# 232947

    Taipei City, Taipei, 11217

Other trials in Taiwan

Poland4 sites

  • Poradnia Zdrowia Psychicznego /ID# 232878

    Chełmno, 86-200

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

    Gdansk, Pomeranian Voivodeship, 80-546

  • Specjalistyczny Gabinet Lekarski /ID# 232702

    Lublin, Lublin Voivodeship, 20-582

  • Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170

    Poznan, Silesian Voivodeship, 60-744

Other trials in Poland

Malaysia2 sites

  • Hospital Raja Permaisuri Bainun /ID# 233114

    Ipoh, Perak, 30450

  • University Malaya Med Ctr /ID# 233108

    Kuala Lumpur, 59100

Other trials in Malaysia

Thailand2 sites

  • Maharaj Nakorn Chiang Mai Hospital /ID# 232860

    Chiang Mai, 50200

  • Suan Prung Psychiatric Hospital /ID# 232862

    Muang, 50100

Other trials in Thailand

Puerto Rico1 site

  • INSPIRA Clinical Research /ID# 232704

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

  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
Being tested
Cariprazine, Placebo
Medical subject headings
Mania, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CariprazineDrug

    Cariprazine capsules, oral administration, once daily

  • PlaceboDrug

    Matching placebo capsules, oral administration, once daily

Study groups in NCT03573297
Study groupRoleWhat they receive
Double-Blind Cariprazine 3.0 mg/dayExperimentalParticipants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.
Receives: Drug: Cariprazine
Double-Blind Cariprazine 1.5 mg/dayExperimentalParticipants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
Receives: Drug: Cariprazine
Double-Blind PlaceboPlacebo comparatorParticipants randomized to receive placebo QD for up to 39 weeks.
Receives: Drug: Placebo
Open Label TreatmentExperimentalParticipants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
Receives: Drug: Cariprazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Week 16 to Week 55

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start15 Jun 2018
  3. Primary completion5 Sep 2022
  4. Study completion5 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
901 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573297
Sponsor's protocol ID
RGH-MD-25
Other IDs
2017-000803-25, 2017
Status last verified
Sep 2023
First submitted
5 Jun 2018
Last updated
28 Sep 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Bipolar I Disorder and Mania, run by AbbVie at 108 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Russia, Ukraine, Bulgaria, Serbia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period (time frame: From Week 16 to Week 55). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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