Bipolar DisorderPhase 3NCT01058096

Safety and Efficacy of Cariprazine for Mania

A Phase 3 study testing Cariprazine in people with Bipolar Disorder and Mania, run by Forest Laboratories at 28 sites in 2 countries.

Completed

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

Official record

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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: Bipolar Disorder, Mania
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: 323 participants
Where: 28 sitesin 2 countries
Study dates: Feb 2010to Jul 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

28 sites in 2 countries.

Country

City, postcode or hospital

28 sites in 2 countries

India18 sites

Forest Investigative Site 103
Ahmedabad, Gujarat, 380013
Forest Investigative Site 120
Ahmedabad, Gujarat, 380015
Forest Investigative Site 105
Bangalore, Karnataka, 560010
Forest Investigative Site 107
Bangalore, Karnataka, 560027
Forest Investigative Site 121
Chennai, Tamil Nadu, 600003
Forest Investigative Site 101
Chhatrapati Sambhajinagar, Maharashtra, 431005
Forest Investigative Site 109
Kanpur, Uttar Pradesh, 200005
Forest Investigative Site 119
Lucknow, Uttar Pradesh, 226006
Forest Investigative Site 118
Mangalore, Karnataka, 575001
Forest Investigative Site 113
Mangalore, Karnataka, 575018
Forest Investigative Site 115
Manipal, Karnataka, 576104
Forest Investigative Site 114
Mysore, Karnataka, 570004
Forest Investigative Site 110
Nashik, Maharashtra, 422101
Forest Investigative Site 111
Pune, Maharashtra, 411004
Forest Investigative Site 104
Pune, Maharashtra, 411030
Forest Investigator Site 108
Varanasi, Durgakund, 221005
Forest Investigative Site 106
Vijayawada, Andhra Pradesh, 520002
Forest Investigative Site 112
Vizag, Andhra Pradesh, 530017

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United States10 sites

Forest Investigative Site 009
Chicago, Illinois, 60640
Forest Investigative Site 008
Cleveland, Ohio, 44109
Forest Investigative Site 003
Creve Couer, Missouri, 63141
Forest Investigative Site 001
Flowood, Mississippi, 39232
Forest Investigative Site 002
Houston, Texas, 77008
Forest Investigative Site 006
Lake Charles, Louisiana, 70601
Forest Investigative Site 004
Long Beach, California, 90813
Forest Investigative Site 010
Oklahoma City, Oklahoma, 73116
Forest Investigative Site 005
Riverside, California, 92506
Forest Investigative Site 007
San Diego, California, 92123

Other trials in United States

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

Conditions: Bipolar Disorder, Mania
Being tested: Cariprazine, Placebo
Keywords: Acute Mania, Bipolar I Disorder
Medical subject headings: Bipolar Disorder, 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.
PlaceboDrug
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.

Study groups in NCT01058096
Study group	Role	What they receive
Cariprazine	Experimental	Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. Receives: Drug: Cariprazine
Placebo	Placebo comparator	Placebo 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.

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 5-point scale (0-4) and 4-items on a 9-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 was a mixed model for repeated measurements (MMRM) observed cases (OC), 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)

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 was based on a MMRM using the observed cases (OC) 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.

Feb 2010Jul 2011

First posted28 Jan 2010 (estimated)
Study startFeb 2010
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01058096
Sponsor's protocol ID: RGH-MD-32
Status last verified: Mar 2017
First submitted: 27 Jan 2010
Last updated: 17 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01058096
Acronym / sponsor ID: RGH-MD-32
Conditions: Bipolar Disorder, Mania
Keywords: Acute Mania, Bipolar I Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Gedeon Richter Ltd.
Study start: Feb 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 28 Jan 2010 (estimated)
Results: Posted 17 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cariprazine	Experimental	Drug: CariprazineCariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CariprazinePatients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.	Drug	Cariprazine
PlaceboPatients who meet eligibility criteria will be administered a once daily oral dose of placebo.	Drug	Placebo

Primary outcome

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
Time frame: Baseline, 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 5-point scale (0-4) and 4-items on a 9-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 was a mixed model for repeated measurements (MMRM) observed cases (OC), 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.

1 secondary outcome

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
Time frame: Baseline, Week 3

Results and safety

Results posted to the registry on 17 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	154	106
Cariprazine	158	108

Primary outcome: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3

Time frame: Baseline, Week 3. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 152	Cariprazine n = 158
Value	-15.3 (0.9)	-19.6 (0.9)

Placebo vs Cariprazine: Least Squares Mean Difference: -4.3 (95% CI -6.7 to -1.9), p = 0.0004, Mixed Models Analysis

Population analysed: Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: First dose of study drug to 30 days past last dose (Up to 51 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 154 (3.2%)	69 of 154 (44.8%)	Not reported
Cariprazine	6 of 158 (3.8%)	110 of 158 (69.6%)	Not reported

Limitations and caveats (from the sponsor): All participants from 1 investigative site are excluded due to GCP violations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31344528McIntyre 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.
Derived from this study: PubMed 29017067Earley 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Diaz, MD study director

Forest Laboratories

28 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Bipolar Disorder and Mania, run by Forest Laboratories at 28 sites in 2 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 17 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 28 sites in India, United States. 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 17 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 NCT01058096, which also lists 2 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 17 Apr 2017.