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ManiaPhase 3NCT01058668

Safety and Efficacy of Cariprazine for Bipolar I Disorder

A Phase 3 study testing Cariprazine in people with Mania and Bipolar I Disorder, run by Forest Laboratories at 66 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

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mania, Bipolar I Disorder
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
497 participants
Where
66 sitesin 6 countries
Study dates
Feb 2010to Dec 2011
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

  • Patients who have provided informed consent prior to any study specific procedures
  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
  • Voluntarily hospitalized for current manic episode
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Who cannot join

  • Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months

Trial locations and contacts

66 sites in 6 countries.

66 sites in 6 countries

United States23 sites

  • Forest Investigative Site 026

    Atlanta, Georgia, 30308

  • Forest Investigative Site 014

    Bothell, Washington, 98011

  • Forest Investigative Site 008

    Cedarhurst, New York, 11516

  • Forest Investigative Site 012

    Cerritos, California, 90703

  • Forest Investigative Site 010

    Costa Mesa, California, 92626

  • Forest Investigative Site 021

    Greenwood, Indiana, 46143

  • Forest Investigative Site 011

    Hoffman Estates, Illinois, 60169

  • Forest Investigative Site 013

    Honolulu, Hawaii, 96813

  • Forest Investigative Site 004

    Irving, Texas, 75062

  • Forest Investigative Site 002

    Kissimmee, Florida, 34741

  • Forest Investigative Site 018

    Little Rock, Arkansas, 72211

  • Forest Investigative Site 015

    Memphis, Tennessee, 38119

  • Forest Investigative Site 016

    New Britain, Connecticut, 06050

  • Forest Investigative Site 005

    Oceanside, California, 92056

  • Forest Investigative Site 003

    Orlando, Florida, 32821

  • Forest Investigative Site 019

    Philadelphia, Pennsylvania, 19139

  • Forest Investigative Site 006

    Rockville, Maryland, 20850

  • Forest Investigative Site 023

    San Diego, California, 92102

  • Forest Investigative Site 017

    San Diego, California, 92103

  • Forest Investigative Site 024

    Santa Ana, California, 92701

  • Forest Investigative Site 001

    Shreveport, Louisiana, 71115

  • Forest Investigative Site 025

    St Louis, Missouri, 63118

  • Forest Investigative Site 007

    Washington D.C., District of Columbia, 20016

Other trials in United States

Ukraine14 sites

  • Forest Investigative Site 308

    Dnipropetrovsk, 49027

  • Forest Investigative Site 315

    Dnipropetrovsk, 49115

  • Forest Investigative Site 301

    Donetsk, 83008

  • Forest Investigative Site 307

    Kharkiv, 61068

  • Forest Investigative Site 310

    Kharkiv, 61068

  • Forest Investigative Site 304

    Kyiv, 01030

  • Forest Investigative Site 305

    Kyiv, 02660

  • Forest Investigative Site 303

    Kyiv, 04080

  • Forest Investigative Site 309

    Kyiv, 04080

  • Forest Investigative Site 312

    Kyiv, 08631

  • Forest Investigative Site 306

    Luhansk, 91045

  • Forest Investigative Site 311

    Lviv, 79021

  • Forest Investigative Site 302

    Odesa, 65006

  • Forest Investigative Site 314

    Poltava, 36006

Other trials in Ukraine

Romania11 sites

  • Forest Investigative Site 209

    Arad, 310022

  • Forest Investigative Site 203

    Bucharest, 041915

  • Forest Investigative Site 205

    Bucharest, 041915

  • Forest Investigative Site 206

    Bucharest, 041915

  • Forest Investigative Site 208

    Bucharest, 041915

  • Forest Investigative Site 202

    Constanța, 900002

  • Forest Investigative Site 210

    Craiova, Dolj, 200745

  • Forest Investigative Site 201

    Craiova, 200260

  • Forest Investigative Site 212

    Focşani, Vrancea, 620165

  • Forest Investigative Site 204

    Targoviste, Dâmbovița County, 130086

  • Forest Investigative Site 211

    Timișoara, Timiș County, 300182

Other trials in Romania

Russia9 sites

  • Forest Investigative Site 501

    Lipetsk, 398007

  • Forest Investigative Site 503

    Moscow, 115522

  • Forest Investigative Site 507

    Moscow, 115522

  • Forest Investigative Site 510

    Moscow, 115522

  • Forest Investigative Site 506

    Saint Petersburg, 190005

  • Forest Investigative Site 508

    Saint Petersburg, 190121

  • Forest Investigative Site 509

    Samara, 443016

  • Forest Investigative Site 504

    Saratov, 410028

  • Forest Investigative Site 502

    Smolensk, 214019

Other trials in Russia

Serbia5 sites

  • Forest Investigative Site 403

    Belgrade, 11000

  • Forest Investigative Site 404

    Belgrade, 11000

  • Forest Investigative Site 405

    Belgrade, 11000

  • Forest Investigative Site 402

    Kragujevac, 34000

  • Forest Investigative Site 401

    Senta, 24400

Other trials in Serbia

Croatia4 sites

  • Forest Investigative Site 607

    Rijeka, 51 000

  • Forest Investigative Site 602

    Zagreb, 10 000

  • Forest Investigative Site 605

    Zagreb, 10 000

  • Forest Investigative Site 606

    Zagreb, 10 090

Other trials in Croatia

About this study

Official title: A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Being tested
Cariprazine, Placebo
Keywords
Acute Mania, Bipolar I Disorder
Medical subject headings
Mania

What participants receive

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

  • CariprazineDrug

    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

  • PlaceboDrug

    Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

Study groups in NCT01058668
Study groupRoleWhat they receive
Cariprazine (3-6 mg/day)ExperimentalCariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Receives: Drug: Cariprazine
Cariprazine (6-12 mg/day)ExperimentalCariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Receives: Drug: Cariprazine
PlaceboPlacebo comparatorPlacebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3

    The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.

    Measured: Baseline, Week 3

Secondary outcomes (1)

  1. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3

    The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.

    Measured: Baseline, Week 3

Timeline

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

  1. First posted29 Jan 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionDec 2011
  4. Study completionDec 2011

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
497 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01058668
Sponsor's protocol ID
RGH-MD-33
Status last verified
Mar 2017
First submitted
27 Jan 2010
Last updated
12 Apr 2017
Data monitoring committee
No

Publications

  • McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.

    PubMed 31344528

  • Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.

    PubMed 29017067

  • Calabrese JR, Keck PE Jr, Starace A, Lu K, Ruth A, Laszlovszky I, Nemeth G, Durgam S. Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study. J Clin Psychiatry. 2015 Mar;76(3):284-92. doi: 10.4088/JCP.14m09081.

    PubMed 25562205

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Mania and Bipolar I Disorder, run by Forest Laboratories at 66 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 4 inclusion and 1 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Ukraine, Romania, Russia, Serbia 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 12 Apr 2017). 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 Young Mania Rating Scale (YMRS) Total Score at Week 3 (time frame: Baseline, Week 3). 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 NCT01058668, which also lists 3 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 12 Apr 2017.

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