SchizophreniaPhase 2NCT00044005

Safety and Tolerability Study of Drug to Treat Schizophrenia

A Phase 2 study testing Lurasidone 20 mg, Lurasidone 40 mg and Lurasidone 80mg in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 26 sites in United States.

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 purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Lurasidone 20 mg, Lurasidone 40 mg and Lurasidone 80mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 26 sitesUnited States
Study dates: Sep 2002to Nov 2003
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Successful completion of participation in protocol #D1050049

Who cannot join

Substance abuse
Prolactin level of ≥200ng/mL at baseline
Pregnancy

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Community Clinical Research
Austin, Texas, 78756
FutureSearch Trials
Austin, Texas, 78756
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, 77401
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, 35209
Institute for Psychopharmacology Research
Cerritos, California, 90703
Comprehensive Clinical Research, CNS
Clementon, New Jersey, 08021
St. Paul Medical Center
Dallas, Texas, 75235
CNS, Inc.
Falls Church, Virginia, 22041
CNS Network
Garden Grove, California, 92845
California Clinical Trials Medical Group
Glendale, California, 91206
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60194
Hawaii Research Center
Honolulu, Hawaii, 96826
ClinSearch, Inc.
Kenilworth, New Jersey, 07033
Optimum Health Services
La Mesa, California, 91942
Comprehensive Neuroscience. Inc.
Melbourne, Florida, 32935
Medstream, Inc.
Milwaukee, Wisconsin, 53210
Lake Mead Hospital
North Las Vegas, Nevada, 89030
Segal Institute for Clinical Research
North Miami, Florida, 33161
American Medical Research
Oak Brook, Illinois, 60523
University of California, Irvine
Orange, California, 92868
Quantum Clinical Services Group
Philadelphia, Pennsylvania, 19139
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
California Neuropsychopharmacology Clinical Research Institute
San Diego, California, 92126
University of South Florida
Tampa, Florida, 33613
Psychiatric Institute of Washington
Washington D.C., District of Columbia, 20016
Coordinated Research of Florida, Inc
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Conditions: Schizophrenia
Being tested: Lurasidone 20 mg, Lurasidone 40 mg, Lurasidone 80mg
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 20 mgDrug
Lurasidone 20mg oral tablet taken once daily for 6-months
Lurasidone 40 mgDrug
Lurasidone 40mg oral tablets taken once daily
Lurasidone 80mgDrug
Lurasidone 80mg oral tablet taken once daily

Study groups in NCT00044005
Study group	Role	What they receive
Lurasidone 20 mg	Experimental	Lurasidone 20 mg oral tablet Receives: Drug: Lurasidone 20 mg
Lurasidione 40 mg	Experimental	Lurasidone 40 mg oral tablet Receives: Drug: Lurasidone 40 mg
Lurasidone 80mg	Experimental	Lurasidone 80mg oral tablet Receives: Drug: Lurasidone 80mg

What is being measured

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

Number of Participants With Adverse Events
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
Measured: 6-months

Timeline

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

Sep 2002Nov 2003

First posted20 Aug 2002 (estimated)
Study startSep 2002
Primary completionNov 2003
Study completionNov 2003

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00044005
Sponsor's protocol ID: D1050174
Status last verified: Mar 2014
First submitted: 16 Aug 2002
Last updated: 17 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Schizophrenia trials

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: A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT00044005
Acronym / sponsor ID: D1050174
Conditions: Schizophrenia
Keywords: Schizophrenia, Latuda, Lurasidone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2002
Primary completion: Nov 2003 (actual)
Study completion: Nov 2003 (actual)
First posted: 20 Aug 2002 (estimated)
Results: Posted 19 May 2011

Clinical summary

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

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Lurasidone 20 mg	Experimental	Drug: Lurasidone 20 mgLurasidone 20 mg oral tablet
Lurasidione 40 mg	Experimental	Drug: Lurasidone 40 mgLurasidone 40 mg oral tablet
Lurasidone 80mg	Experimental	Drug: Lurasidone 80mgLurasidone 80mg oral tablet

Who may qualify

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

Key inclusion criteria (1 listed)

Successful completion of participation in protocol #D1050049

Key exclusion criteria (3 listed)

Substance abuse
Prolactin level of ≥200ng/mL at baseline
Pregnancy

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 20 mgLurasidone 20mg oral tablet taken once daily for 6-months	Drug	Lurasidone 20 mg
Lurasidone 40 mgLurasidone 40mg oral tablets taken once daily	Drug	Lurasidione 40 mg
Lurasidone 80mgLurasidone 80mg oral tablet taken once daily	Drug	Lurasidone 80mg

Primary outcome

Number of Participants With Adverse Events
Time frame: 6-months
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.

Results and safety

Results posted to the registry on 19 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lurasidone 20 mg	32	13
Lurasidone 40 mg	33	19
Lurasidone 80mg	33	11

Primary outcome: Number of Participants With Adverse Events

Time frame: 6-months. Number. Unit: participants

Measure	Lurasidone 20 mg n = 32	Lurasidone 40 mg n = 33	Lurasidone 80mg n = 33
Value	19 (7.8)	22 (12.4)	18 (10.7)

Population analysed: No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lurasidone 20 mg	3 of 32 (9.4%)	19 of 32 (59.4%)	Not reported
Lurasidone 40 mg	6 of 33 (18.2%)	22 of 33 (66.7%)	Not reported
Lurasidone 80mg	3 of 33 (9.1%)	18 of 33 (54.5%)	Not reported

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.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

26 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 20 mg, Lurasidone 40 mg and Lurasidone 80mg in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 26 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 1 inclusion and 3 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 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 19 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 Participants With Adverse Events (time frame: 6-months). 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 NCT00044005.

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.