Bipolar I DisorderPhase 3NCT01059539
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
A Phase 3 study testing Cariprazine in people with Bipolar I Disorder, run by Forest Laboratories at 35 sites in 4 countries.
Trial summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Cariprazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 28 Feb 2010to 29 Feb 2012
- 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).
- Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
- Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).
Who cannot join
- Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
United States24 sites
Forest Investigative Site 017
Austin, Texas, 78731
Forest Investigative Site 014
Austin, Texas, 78754
Forest Investigative Site 001
Bradenton, Florida, 34208
Forest Investigative Site 010
Carson, California, 90746
Forest Investigative Site 020
Cerritos, California, 90703
Forest Investigative Site 005
Cincinnati, Ohio, 45219
Forest Investigative Site 022
Creve Coeur, Missouri, 63141
Forest Investigative Site 018
DeSoto, Texas, 75115
Forest Investigative Site 009
Escondido, California, 92025
Forest Investigative Site 024
Flowood, Mississippi, 39232
Forest Investigative Site 006
Fort Lauderdale, Florida, 33308
Forest Investigative Site 004
Garden Grove, California, 92845
Forest Investigative Site 019
Houston, Texas, 77008
Forest Investigative Site 013
Kissimmee, Florida, 34741
Forest Investigative Site 012
Las Vegas, Nevada, 89102
Forest Investigative Site 011
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 021
Rockville, Maryland, 20850
Forest Investigative Site 003
Saint Charles, Missouri, 63301
Forest Investigative Site 016
San Diego, California, 92102
Forest Investigative Site 007
Santa Ana, California, 92701
Forest Investigative Site 015
Springdale, Arkansas, 72764
Forest Investigative Site 025
St Louis, Missouri, 63118
Forest Investigative Site 023
Washington D.C., District of Columbia, 20016
Forest Investigative Site 002
Willingboro, New Jersey, 08046
Hungary5 sites
Forest Investigative Site 301
Budapest, 1083
Forest Investigative Site 302
Budapest, 1135
Forest Investigative Site 309
Gyula, Bekes County, 5700
Forest Investigative Site 306
Nyíregyháza, 4400
Forest Investigative Site 308
Szombathely, 9700
Poland5 sites
Forest Investigative Site 407
Gdansk, 80-952
Forest Investigative Site 408
Gmina Świecie, 86-100
Forest Investigative Site 401
Gorlice, 38-300
Forest Investigative Site 404
Katowice, Silesian, 40-340
Forest Investigative Site 402
Tuszyn, Kodz, 95-080
About this study
Official title: A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
- Conditions
- Bipolar I Disorder
- Being tested
- Cariprazine
- Keywords
- Mania, 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
Also called RGH-188
Cariprazine was supplied in capsules.
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine 3-12 mg/day for 16 weeks | Experimental | Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator. Receives: Drug: Cariprazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the YMRS Total Score at Week 16
The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient'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 each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement.
Measured: Baseline to Week 16
Secondary outcomes (1)
Change From Baseline in the MADRS Total Score at Week 16
The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale that evaluates the patient's depressive symptomatology during the previous week. Patients are rated on 10 items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point (0-6) scale. The total score can range from 0 to 42. A higher score indicates greater depressive symptomatology. A negative change score indicates improvement.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study start28 Feb 2010
- Primary completion29 Feb 2012
- Study completion29 Feb 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar I 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Diaz, MD, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059539
- Sponsor's protocol ID
- RGH-MD-36
- Status last verified
- May 2019
- First submitted
- 27 Jan 2010
- Last updated
- 13 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ketter TA, Sachs GS, Durgam S, Lu K, Starace A, Laszlovszky I, Nemeth G. The safety and tolerability of cariprazine in patients with manic or mixed episodes associated with bipolar I disorder: A 16-week open-label study. J Affect Disord. 2018 Jan 1;225:350-356. doi: 10.1016/j.jad.2017.08.040. Epub 2017 Aug 18.
PubMed 28843918
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT01059539
- Acronym / sponsor ID
- RGH-MD-36
- Conditions
- Bipolar I Disorder
- Keywords
- Mania, Acute mania, Bipolar I disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Study start
- 28 Feb 2010 (actual)
- Primary completion
- 29 Feb 2012 (actual)
- Study completion
- 29 Feb 2012 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 13 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cariprazine 3-12 mg/day for 16 weeks | Experimental | Drug: CariprazineParticipants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator. |
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).
- Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
- Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).
Key exclusion criteria (1 listed)
- Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.
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 |
|---|---|---|
| CariprazineAlso: RGH-188Cariprazine was supplied in capsules. | Drug | Cariprazine 3-12 mg/day for 16 weeks |
Primary outcome
Change From Baseline in the YMRS Total Score at Week 16
Time frame: Baseline to Week 16
The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient'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 each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement.
1 secondary outcome
Change From Baseline in the MADRS Total Score at Week 16
Time frame: Baseline to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28843918Ketter TA, Sachs GS, Durgam S, Lu K, Starace A, Laszlovszky I, Nemeth G. The safety and tolerability of cariprazine in patients with manic or mixed episodes associated with bipolar I disorder: A 16-week open-label study. J Affect Disord. 2018 Jan 1;225:350-356. doi: 10.1016/j.jad.2017.08.040. Epub 2017 Aug 18.
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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
35 sites in 4 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 I Disorder, run by Forest Laboratories at 35 sites in 4 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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Hungary, Poland, Spain. 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. 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 13 Jun 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 YMRS Total Score at Week 16 (time frame: Baseline to Week 16). 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 NCT01059539, which also lists 1 linked publication.
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 13 Jun 2019.