SchizophreniaPhase 2NCT00044044

A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

A Phase 2 study testing Lurasidone 20 mg, Lurasidone 40mg and Lurasidone 80 mg in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 34 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 efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with 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 20 mg, Lurasidone 40mg and Lurasidone 80 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 356 participants
Where: 34 sitesUnited States
Study dates: Jul 2002to May 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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The patient has a primary diagnosis of schizophrenia
The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
The patient has had a duration of illness of at least one year.
The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
The patient is able to remain off antipsychotic medication for a 4 day washout period

Who cannot join

The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline
Pregnancy

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Community Clinical Research
Austin, Texas, 78756
FutureSearch Trials
Austin, Texas, 78756
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, 77401
Northwest Clinical Research Center
Belleview, Washington, 98004
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, 35209
Institute for Psychopharmacology Research
Cerritos, California, 90703
Psychiatric Professional Services Inc
Cincinnati, Ohio, 45267
Comprehensive Clinical Research CNS, PC
Clementon, New Jersey, 08021
St. Paul Medical Center
Dallas, Texas, 75235
University Hills Clinical Research
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 - Dept. of Psychiatry
Philadelphia, Pennsylvania, 19141
Centers for Behavioral Health, LLC
Rockville, Maryland, 20850
Affiliated Research Institute
San Diego, California, 92108
Sharp Mesa Vista Hospital
San Diego, California, 92123
California Neuropsychopharmacolgoy Clinical Research Insitute
San Diego, California, 92126
Carman Research
Smyrna, Georgia, 30080
University of South Florida
Tampa, Florida, 33613
Comprehensive Neuroscience. Inc.
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 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Conditions: Schizophrenia
Being tested: Lurasidone 20 mg, Lurasidone 40mg, Lurasidone 80 mg, Haloperidol 10mg, Placebo
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/day tablets
Lurasidone 40mgDrug
Lurasidone 40mg/day tablets
Lurasidone 80 mgDrug
Lurasidone 80mg/day - 2 40mg tablets
Haloperidol 10mgDrug
Haloperidol 10mg/day tablets
PlaceboDrug
Matching Placebo to Lurasdione and Haloperidol

Study groups in NCT00044044
Study group	Role	What they receive
Lurasidone 20 mg	Experimental	Lurasidone 20 mg tablets Receives: Drug: Lurasidone 20 mg
Lurasidone 40 mg	Experimental	Lurasidone 40 mg tablets Receives: Drug: Lurasidone 40mg
Lurasidone 80 mg	Experimental	Lurasidone 2 40 mg tablets Receives: Drug: Lurasidone 80 mg
Haloperidol 10mg	Active comparator	Haloperidol 10mg tablets Receives: Drug: Haloperidol 10mg
Placebo	Placebo comparator	Matching Placebo to Lurasidone and Haloperidol Receives: Drug: Placebo

What is being measured

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

Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Measured: Baseline and 6 weeks

Secondary outcomes (3)

Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Measured: Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
The MADRS is a 10-item rating scale that assesses apparent and reported 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 scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Measured: Baseline and 6 weeks

Timeline

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

Jul 2002May 2003

First posted20 Aug 2002 (estimated)
Study startJul 2002
Primary completionMay 2003
Study completionMay 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.
Publications (1)Papers the sponsor has linked to this study.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00044044
Sponsor's protocol ID: D1050049
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

Publications

Storman D, Koperny M, Styczen K, Datka W, Jaeschke RR. Lurasidone versus typical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2025 Jan 20;1(1):CD012429. doi: 10.1002/14651858.CD012429.pub2.
PubMed 39831535

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 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
ClinicalTrials.gov ID: NCT00044044
Acronym / sponsor ID: D1050049
Conditions: Schizophrenia
Keywords: Schizophrenia, Latuda, Lurasidone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 356 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2002
Primary completion: May 2003 (actual)
Study completion: May 2003 (actual)
First posted: 20 Aug 2002 (estimated)
Results: Posted 12 Apr 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 efficacy of the drug SM-13496 compared to a placebo and to haloperidol 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: 5

Arm	Type	Receives
Lurasidone 20 mg	Experimental	Drug: Lurasidone 20 mgLurasidone 20 mg tablets
Lurasidone 40 mg	Experimental	Drug: Lurasidone 40mgLurasidone 40 mg tablets
Lurasidone 80 mg	Experimental	Drug: Lurasidone 80 mgLurasidone 2 40 mg tablets
Haloperidol 10mg	Active comparator	Drug: Haloperidol 10mgHaloperidol 10mg tablets
Placebo	Placebo comparator	Drug: PlaceboMatching Placebo to Lurasidone and Haloperidol

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

The patient has a primary diagnosis of schizophrenia
The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
The patient has had a duration of illness of at least one year.
The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
The patient is able to remain off antipsychotic medication for a 4 day washout period

Key exclusion criteria (3 listed)

The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/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/day tablets	Drug	Lurasidone 20 mg
Lurasidone 40mgLurasidone 40mg/day tablets	Drug	Lurasidone 40 mg
Lurasidone 80 mgLurasidone 80mg/day - 2 40mg tablets	Drug	Lurasidone 80 mg
Haloperidol 10mgHaloperidol 10mg/day tablets	Drug	Haloperidol 10mg
PlaceboMatching Placebo to Lurasdione and Haloperidol	Drug	Placebo

Primary outcome

Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
Time frame: Baseline and 6 weeks
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.

3 secondary outcomes

Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
Time frame: Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
Time frame: Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
Time frame: Baseline and 6 weeks

Results and safety

Results posted to the registry on 12 Apr 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
20 mg	71	27
40 mg	69	28
80 mg	71	31
10 mg Haloperidol	73	29
Placebo	72	36

Primary outcome: Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score

Time frame: Baseline and 6 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	20 mg n = 71	40 mg n = 65	80 mg n = 70	10 mg Haloperidol n = 72	Placebo n = 71
Value	-5.0 (1.38)	-5.2 (1.44)	-8.0 (1.40)	-9.8 (1.37)	-7.9 (1.38)

20 mg vs 40 mg vs 80 mg vs 10 mg Haloperidol vs Placebo: p <0.05, ANCOVA

Population analysed: Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20 mg	4 of 71 (5.6%)	49 of 71 (69%)	Not reported
40 mg	9 of 67 (13.4%)	51 of 67 (76.1%)	Not reported
80 mg	3 of 71 (4.2%)	51 of 71 (71.8%)	Not reported
10 mg Haloperidol	5 of 72 (6.9%)	58 of 72 (80.6%)	Not reported
Placebo	7 of 72 (9.7%)	50 of 72 (69.4%)	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.
Derived from this study: PubMed 39831535Storman D, Koperny M, Styczen K, Datka W, Jaeschke RR. Lurasidone versus typical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2025 Jan 20;1(1):CD012429. doi: 10.1002/14651858.CD012429.pub2.

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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.

34 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 40mg and Lurasidone 80 mg in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 34 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 5 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 34 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 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 12 Apr 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?

Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score (time frame: Baseline and 6 weeks). 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 NCT00044044, 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 17 Apr 2014.