SchizophreniaPhase 2NCT00088621
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
A Phase 2 study testing Lurasidone 80mg tablet in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 21 sites in United States.
Trial summary
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone 80mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 2004to Oct 2005
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
- Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either:
- Successfully completed
- OR
- Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Community Clinical Research
Austin, Texas, 78729
Future Search Trials
Austin, Texas, 78756
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, 77401
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, 35209
Comprehensive NeuroScience
Cerritos, California, 90703
CNS Research Institute
Clementon, New Jersey, 08021
InSite Clinical Research
DeSoto, Texas, 75115
CBH Health, L.L.C - Dominion Hospital
Falls Church, Virginia, 22044
Segal Institute for Clinical Research
Fort Lauderdale, Florida, 33301
Collaborative Neuro Science Network, Inc.
Garden Grove, California, 92845
Comprehensive Neuroscience, Inc.
Hoffman Estates, Illinois, 60194
Optimum Health Services
La Mesa, California, 91942
Study site
Las Vegas, Nevada, 89102
Summit Research Group
Little Rock, Arkansas, 72211
Segal Institute for Clinical Research
North Miami, Florida, 33161
Quantum Clinical Services Group
Philadelphia, Pennsylvania, 19139
California Clinical Trials
San Diego, California, 92123
CA Neutopsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, 92126
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, 33613
Pacific Clinical Research
Upland, California, 91786
Comprehensive NeuroScience, Inc
Washington D.C., District of Columbia, 20016
About this study
Official title: An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Read the detailed description
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone 80mg tablet
- Keywords
- Schizophrenia, Latuda, Lurasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone 80mg tabletDrug
Also called Lurasidone
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone 80 mg tablet | Experimental | Lurasidone 80mg oral tablet taken once a day Receives: Drug: Lurasidone 80mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study startJul 2004
- Primary completionOct 2005
- Study completionOct 2005
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088621
- Sponsor's protocol ID
- D1050199
- Status last verified
- Mar 2014
- First submitted
- 30 Jul 2004
- Last updated
- 17 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT00088621
- Acronym / sponsor ID
- D1050199
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Latuda, Lurasidone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 2 Aug 2004 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Detailed description
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lurasidone 80 mg tablet | Experimental | Drug: Lurasidone 80mg tabletLurasidone 80mg oral tablet taken once a day |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Lurasidone 80mg tabletAlso: Lurasidone | Drug | Lurasidone 80 mg tablet |
Primary outcome
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director, MD study director
Sumitomo Pharma America, Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lurasidone 80mg tablet in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 21 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?
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 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 May 2011). 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?
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study (time frame: 1 year). 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 17 Apr 2014.