SchizophreniaPhase 1NCT01376076
Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
A Phase 1 study testing Cariprazine and Risperidone/Moxifloxacin in people with Schizophrenia, run by Forest Laboratories at 4 sites in United States.
Trial summary
This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cariprazine and Risperidone/Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women, age 18 to 50, inclusive
- Symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening
- Negative pregnancy test
- Normal physical examination results, vital signs, and clinical lab test results
Who cannot join
- Axis II disorder severe enough to interfere with the study
- Smoking more than 20 cigarettes a day
- History or presence of cardiovascular disorder
- Pregnant/breast-feeding and/or planning to become pregnant/breast-feed
- Imminent risk of injuring self or others or causing significant property damage
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Forest Investigative Site 001
Glendale, California, 91206
Forest Investigative Site 003
Houston, Texas, 77008
Forest Investigative Site 004
Long Beach, California, 90806
Forest Investigative Site 002
Willingboro, New Jersey, 08046
About this study
Official title: Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Cariprazine, Risperidone/Moxifloxacin
- Keywords
- schizophrenia, QTc, cardiac repolarization
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CariprazineDrug
Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.
Risperidone/MoxifloxacinDrug
Patients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35.
Risperidone/MoxifloxacinDrug
Patients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine Receives: Drug: Cariprazine |
| 2A | Placebo comparator | Double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35 Receives: Drug: Risperidone/Moxifloxacin |
| 2B | Placebo comparator | Double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35 Receives: Drug: Risperidone/Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate-corrected QT interval (QTc)
The effects of a therapeutic dosage (9 mg/day) and a supratherapeutic dosage (18 mg/day) of cariprazine on cardiac repolarization as determined by heart-rate-corrected QT intervals will be assessed on Day 20 and Day 34, respectively. The assay sensitivity of moxifloxacin 400 mg/day will be assessed on Day 6 and Day 35.
Measured: 35 days of double-blind treatment, up to 56 days total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suneeta Ahuja, PhD, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376076
- Sponsor's protocol ID
- RGH-MD-02
- Status last verified
- Feb 2012
- First submitted
- 16 Jun 2011
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01376076
- Acronym / sponsor ID
- RGH-MD-02
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, QTc, cardiac repolarization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CariprazineSequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine |
| 2A | Placebo comparator | Drug: Risperidone/MoxifloxacinDouble blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35 |
| 2B | Placebo comparator | Drug: Risperidone/MoxifloxacinDouble blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men or women, age 18 to 50, inclusive
- Symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening
- Negative pregnancy test
- Normal physical examination results, vital signs, and clinical lab test results
Key exclusion criteria (5 listed)
- Axis II disorder severe enough to interfere with the study
- Smoking more than 20 cigarettes a day
- History or presence of cardiovascular disorder
- Pregnant/breast-feeding and/or planning to become pregnant/breast-feed
- Imminent risk of injuring self or others or causing significant property damage
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 meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally. | Drug | 1 |
| Risperidone/MoxifloxacinPatients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35. | Drug | 2A |
| Risperidone/MoxifloxacinPatients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35. | Drug | 2B |
Primary outcome
Heart rate-corrected QT interval (QTc)
Time frame: 35 days of double-blind treatment, up to 56 days total.
The effects of a therapeutic dosage (9 mg/day) and a supratherapeutic dosage (18 mg/day) of cariprazine on cardiac repolarization as determined by heart-rate-corrected QT intervals will be assessed on Day 20 and Day 34, respectively. The assay sensitivity of moxifloxacin 400 mg/day will be assessed on Day 6 and Day 35.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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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.
Suneeta Ahuja, PhD study director
Forest Laboratories
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cariprazine and Risperidone/Moxifloxacin in people with Schizophrenia, run by Forest Laboratories at 4 sites in United States.
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 5 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 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate-corrected QT interval (QTc) (time frame: 35 days of double-blind treatment, up to 56 days total.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2012.