CompletedNCT00044005Updated Apr 17, 2014Results posted

Safety and Tolerability Study of Drug to Treat Schizophrenia

A Phase 2 interventional study of Lurasidone 20 mg and Lurasidone 40 mg in Schizophrenia, sponsored by Sumitomo Pharma America, Inc.. Completed at 26 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-04-17.

Sponsored by Sumitomo Pharma America, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 98
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Conditions studied

Schizophrenia

Browse trials for

Schizophrenia 3,471

Keywords

Schizophrenia
Latuda
Lurasidone

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 98 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Successful completion of participation in protocol #D1050049

Exclusion criteria

Exclusion criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 98 participants (actual)

Study arms

Experimental
Lurasidone 20 mg
Lurasidone 20 mg oral tablet
Drug: Lurasidone 20 mg
Experimental
Lurasidione 40 mg
Lurasidone 40 mg oral tablet
Drug: Lurasidone 40 mg
Experimental
Lurasidone 80mg
Lurasidone 80mg oral tablet
Drug: Lurasidone 80mg

Interventions

DrugLurasidone 20 mg
Lurasidone 20mg oral tablet taken once daily for 6-months
DrugLurasidone 40 mg
Lurasidone 40mg oral tablets taken once daily
DrugLurasidone 80mg
Lurasidone 80mg oral tablet taken once daily

What researchers measure

Primary outcomes

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.
Time frame: 6-months

Results

Posted May 19, 2011

Participant flow

Participant flow — Overall Study
Milestone	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg
Started	32	33	33
Completed	13	19	11
Not completed	19	14	22

Outcome measures

PrimaryNumber 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.

Time frame:: 6-months
Reported as:: Number · participants

Number of Participants With Adverse Events
participants	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg
Number of Participants With Adverse Events	19 ± 7.8	22 ± 12.4	18 ± 10.7

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lurasidone 20 mg	—	3/32 (9.4%)	19/32 (59.4%)
Lurasidone 40 mg	—	6/33 (18.2%)	22/33 (66.7%)
Lurasidone 80mg	—	3/33 (9.1%)	18/33 (54.5%)

Most frequent serious events

Most frequent serious events
Event	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg
Sinus tachycardiaCardiac disorders	3/32	6/6	3/3
SchizophreniaPsychiatric disorders	2/32	4/33	1/33
Suicidal IdeationPsychiatric disorders	1/32	0/33	1/33
FallInjury, poisoning and procedural complications	0/32	1/33	0/33
Lower Limb FractureInjury, poisoning and procedural complications	0/32	1/33	0/33
Pelvic FractureInjury, poisoning and procedural complications	0/32	1/33	0/33
HypokalaemiaMetabolism and nutrition disorders	0/32	1/33	0/33
Suicidal BehaviorPsychiatric disorders	0/32	1/33	1/33
Endotracheal IntubationSurgical and medical procedures	0/32	1/33	0/33

Most frequent other events

Showing 10 of 40

Most frequent other events
Event	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg
DizzinessNervous system disorders	2/32	6/33	1/33
HeadacheNervous system disorders	5/32	5/33	5/33
NasopharyngitisInfections and infestations	3/32	4/33	0/33
SedationNervous system disorders	0/32	4/33	1/33
DepressionPsychiatric disorders	1/32	0/33	4/33
VomitingGastrointestinal disorders	3/32	2/33	3/33
Upper Respiratory Tract InfectionInfections and infestations	3/32	1/33	1/33
InsomniaPsychiatric disorders	3/32	1/33	2/33
NauseaGastrointestinal disorders	1/32	3/33	2/33
ToothacheGastrointestinal disorders	1/32	3/33	2/33

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg	Total
Mean	40.8 ± 7.8	42.2 ± 12.4	40.8 ± 10.7	41.3 ± 10.4

Sex: Female, Male
Sex: Female, Male(Participants)	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg	Total
Female	11	12	5	28
Male	21	21	28	70

Region of Enrollment
Region of Enrollment(participants)	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg	Total
United States	32	33	33	98

Study locations

26 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00044005
Lead sponsor: Sumitomo Pharma America, Inc.
Responsible party: Sponsor
First posted: Aug 20, 2002
Start date: Sep 2002
Primary completion: Nov 2003
Completion: Nov 2003
Results posted: May 19, 2011
Last update: Apr 17, 2014

Study contacts

Medical Director, MD

study director · Sumitomo Pharma America, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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