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Bipolar DisorderPhase 3NCT02670551

Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

A Phase 3 study testing Cariprazine in people with Bipolar Disorder and Depression, run by Forest Laboratories at 74 sites in 6 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

This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder, 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
488 participants
Where
74 sitesin 6 countries
Study dates
17 Mar 2016to 19 Jul 2017
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 without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration
  • Currently treated as an outpatient at the time of enrollment
  • A verified previous manic or mixed episode. Verification must include one of the following sources: --Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania --Hospital records/Medical records --Participant report corroborated by caretaker or previous or current treating clinician
  • 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
  • HAMD-17 item 1 score ≥ 2
  • Clinical Global Impressions-Severity (CGI-S) score ≥ 4
  • Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
  • Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)

Who cannot join

  • Young Mania Rating Scale (YMRS) total score > 12
  • Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
  • Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias
  • History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder
  • ○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study
  • History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1
Show all 20Show fewer
  • Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception: ○ Participants with a positive cannabinoid on entry may be retested before randomization. If the participant remains positive, the participant is no longer eligible ○ Participants positive for opiates on entry, discussion with Study Physician is required.
  • Electroconvulsive therapy in the 3 months before Visit 1
  • Previous lack of response to electroconvulsive therapy
  • Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
  • Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
  • Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
  • Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
  • Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
  • Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
  • Known history of cataracts or retinal detachment
  • Known human immunodeficiency virus infection
  • Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center

Trial locations and contacts

74 sites in 6 countries.

74 sites in 6 countries

United States44 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Radiant Research

    Atlanta, Georgia, 30328

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Neuro-Behavioral Clinical Research

    Canton, Ohio, 44718

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • Patient Priority Clinical Sites

    Cincinnati, Ohio, 45215

  • Ohio State University Department of Psychiatry

    Columbus, Ohio, 43210

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Synergy San Diego

    Escondido, California, 92025

  • Integrated Medical and Behavioral Associates

    Glendale, California, 91204

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090

  • Houston Clinical Trials, LLC

    Houston, Texas, 77098

  • CNS Healthcare

    Jacksonville, Florida, 32256

  • Core Clinical Research

    Kirkland, Washington, 98033

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Lincoln Research, LLC

    Lincoln, Rhode Island, 02865

  • Arkansas Psychiatric Clinic Clinical Research Trials PA

    Little Rock, Arkansas, 72211

  • Apostle Clinical Trials, Inc.

    Long Beach, California, 90813

  • Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Medical & Behavioral Health Research, PC

    New York, New York, 10023

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360

  • Pacific Research Partners, LLC

    Oakland, California, 94612

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Research Across America

    Plano, Texas, 75093

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97214

  • Alliance Research Group

    Richmond, Virginia, 23230

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63304

  • Oregon Center for Clinical Investigations

    Salem, Oregon, 97301

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Summit Research Network Seattle

    Seattle, Washington, 98104

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • Psychiatric Medicine Associates, L.L.C

    Skokie, Illinois, 60076

  • Carman Research

    Smyrna, Georgia, 30080

  • Olympian Clinical Research

    Tampa, Florida, 33609

  • Viking Clinical Research

    Temecula, California, 92591

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas, 77381

  • Pacific Clinical Research Medical Group

    Upland, California, 91786

  • Neuroscience Research Institute Inc.

    Winfield, Illinois, 60190

Other trials in United States

Bulgaria13 sites

  • Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD

    Burgas, 8000

  • SPH - Kardzhali, EOOD

    Kardzhali, 6600

  • MHAT "Dr. Hristo Stambolski", EOOD

    Kazanlak, 6100

  • State Psychiatric Hospital - Lovech

    Lovech, 5500

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • UMHAT "Sv. Georgi", EAD

    Plovdiv, 4000

  • MHC - Ruse, EOOD

    Rousse, 7003

  • MHATNP "Sv.Naum", EAD

    Sofia, 1113

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606

  • Medical Centre "Doverie" AD

    Sofia, 1632

  • MHAT-Targovishte, AD

    Targovishte, 7700

  • DCC "Mladost M" - Varna, OOD

    Varna, 9020

Other trials in Bulgaria

Poland8 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • Przychodnia Srodmiescie Sp. z o. o.

    Bydgoszcz, 85-080

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100

  • Clinical Best Solutions

    Lublin, 20-045

  • Specjalistyczna Praktyka Lekarska Marek Domański

    Lublin, 20-442

  • NZOZ Syntonia

    Pruszcz Gdański, 83-000

  • Torunskie Centrum Psychiatrii Neuromed

    Torun, 87-100

Other trials in Poland

Lithuania5 sites

  • Romuvos klinika, UAB

    Kaunas, 44279

  • Neuromeda, JSC

    Kaunas, 50185

  • Republican Kaunas Hospital Psychiatry Clinic Mariu Division, Public Institution

    Kaunas, 53136

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • 232Antakalnis Psychiatric Consultation Center, Public Institution

    Vilnius, 10204

Other trials in Lithuania

Estonia3 sites

  • Marienthal Center of Psychiatry and Psychology

    Tallinn, 10617

  • West Tallinn Central Hospital

    Tallinn, 13517

  • Tartu University Hospital

    Tartu, 50417

Other trials in Estonia

Puerto Rico1 site

  • INSPIRA Clinical Research

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression

This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

Being tested
Cariprazine, Placebo
Medical subject headings
Bipolar Disorder, Depression

What participants receive

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

  • CariprazineDrug

    Also called VRAYLAR®

  • PlaceboDrug

Study groups in NCT02670551
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
Receives: Drug: Placebo
Cariprazine 1.5 mgExperimentalFollowing a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
Receives: Drug: Cariprazine
Cariprazine 3.0 mgExperimentalFollowing a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 milligram (mg) capsule, one per day, orally beginning on Day 15 for 4 weeks.
Receives: Drug: Cariprazine

What is being measured

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

  1. Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement.

    Measured: Baseline (Week 0) to Week 6

Secondary outcomes (1)

  1. Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6

    The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A negative change from Baseline indicates improvement.

    Measured: Baseline (Week 0) to Week 6

Timeline

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

  1. First posted1 Feb 2016 (estimated)
  2. Study start17 Mar 2016
  3. Primary completion19 Jul 2017
  4. Study completion19 Jul 2017

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02670551
Sponsor's protocol ID
RGH-MD-54
Other IDs
2016-000757-13, 2016
Status last verified
Jan 2019
First submitted
28 Jan 2016
Last updated
30 Jan 2019
Data monitoring committee
No

Publications

  • McIntyre RS, Llorca PM, Aronin LC, Yu J, Nguyen HB. Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials. Adv Ther. 2025 Jan;42(1):246-260. doi: 10.1007/s12325-024-03009-2. Epub 2024 Nov 9.

    PubMed 39520655

  • Jain R, McIntyre RS, Cutler AJ, Earley WR, Nguyen HB, Adams JL, Yatham LN. Efficacy of cariprazine in patients with bipolar depression and higher or lower levels of baseline anxiety: a pooled post hoc analysis. Int Clin Psychopharmacol. 2024 Mar 1;39(2):82-92. doi: 10.1097/YIC.0000000000000500. Epub 2023 Sep 20.

    PubMed 37551609

  • Citrome L, Yatham LN, Patel MD, Barabassy A, Hankinson A, Earley WR. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J Affect Disord. 2021 Jun 1;288:191-198. doi: 10.1016/j.jad.2021.03.076. Epub 2021 Mar 31.

    PubMed 33915374

  • Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021 May 1;286:58-63. doi: 10.1016/j.jad.2021.02.043. Epub 2021 Feb 20.

    PubMed 33677183

  • Yatham LN, Vieta E, McIntyre RS, Jain R, Patel M, Earley W. Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications. Prim Care Companion CNS Disord. 2020 Sep 17;22(5):20m02611. doi: 10.4088/PCC.20m02611.

    PubMed 32942346

  • 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.

    PubMed 31969269

  • Earley W, Burgess MV, Rekeda L, Dickinson R, Szatmari B, Nemeth G, McIntyre RS, Sachs GS, Yatham LN. Cariprazine Treatment of Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Phase 3 Study. Am J Psychiatry. 2019 Jun 1;176(6):439-448. doi: 10.1176/appi.ajp.2018.18070824. Epub 2019 Mar 8.

    PubMed 30845817

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Bipolar Disorder and Depression, run by Forest Laboratories at 74 sites in 6 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 8 inclusion and 20 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Bulgaria, Poland, Lithuania, Estonia and 1 more country. 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 30 Jan 2019). 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?

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6 (time frame: Baseline (Week 0) to Week 6). 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 NCT02670551, which also lists 7 linked publications.

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 30 Jan 2019.

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