SchizophreniaPhase 3NCT00254202

Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

A Phase 3 study testing Iloperidone and Ziprasidone in people with Schizophrenia, run by Vanda Pharmaceuticals at 42 sites in 2 countries.

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 determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Iloperidone and Ziprasidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 593 participants
Where: 42 sitesin 2 countries
Study dates: 18 Nov 2005to 21 Mar 2007
Phase: Phase 3
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

DSM-IV diagnosis of schizophrenia
PANSS-T of at least 70 at screening and baseline

Who cannot join

Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
DSM-IV diagnosis of psychiatric disorder other than schizophrenia

Trial locations and contacts

42 sites in 2 countries.

Country

City, postcode or hospital

42 sites in 2 countries

United States33 sites

Vanda Investigational Site
Anaheim, California, 92805
Vanda Investigational Site
Atlanta, Georgia, 30308
Vanda Investigational Site
Augusta, Georgia, 30912
Vanda Investigational Site
Austin, Texas, 78756
Vanda Investigational Site
Bradenton, Florida, 34208
Vanda Investigational Site
Brooklyn, New York, 11203
Vanda Investigational Site
Cerritos, California, 90703
Vanda Investigational Site
Cincinnati, Ohio, 45267
Vanda Investigational Site
Clementon, New Jersey, 08021
Vanda Investigational Site
Fort Lauderdale, Florida, 33308
Vanda Investigational Site
Garden Grove, California, 92845
Vanda Investigational Site
Glendale, California, 91206
Vanda Investigational Site
Hoffman Estates, Illinois, 60194
Vanda Investigational Site
Houston, Texas, 77057
Vanda Investigational Site
Irving, Texas, 75062
Vanda Investigational Site
Lake Charles, Louisiana, 70601
Vanda Investigational Site
Little Rock, Arkansas, 72211
Vanda Investigational Site
Los Angeles, California, 90048
Vanda Investigational Site
Maitland, Florida, 32751
Vanda Investigational Site
National City, California, 91950
Vanda Investigational Site
Oceanside, California, 92056
Vanda Investigational Site
Paramount, California, 90723
Vanda Investigational Site
Philadelphia, Pennsylvania, 19131
Vanda Investigational Site
Pico Rivera, California, 90660
Vanda Investigational Site
Richmond, Virginia, 23229
Vanda Investigational Site
Rockville, Maryland, 20850
Vanda Investigational Site
Saint Charles, Missouri, 63301
Vanda Investigational Site
San Diego, California, 92123
Vanda Investigational Site
San Diego, California, 92126
Vanda Investigational Site
San Diego, California, 92161
Vanda Investigational Site
Santa Ana, California, 92705
Vanda Investigational Site
St Louis, Missouri, 63118
Vanda Investigational Site
Upland, California, 91786

Other trials in United States

India9 sites

Vanda Investigational Site
Ahmedabad, Gujarat, 380006
Vanda Investigational Site
Aurangabad, Maharashtra, 431005
Vanda Investgational Site
Chennai, Tamil Nadu, 600003
Vanda Investigational Site
Chinawaltair, Visakha Patnam, 530002
Vanda Investigational Site
Jaipur, Rajasthan, 302004
Vanda Investigational Site
Lucknow, Uttar Pradesh, 226003
Vanda Investigational Site
Manipal, Karnataka, 576104
Vanda Investigational Site
Pune, Maharashtra, 411001
Vanda Investigational Site
Tirupati, Andhra Pradesh, 517507

Other trials in India

About this study

Official title: A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.

The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Read the detailed description

Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.

Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Conditions: Schizophrenia
Being tested: Iloperidone, Ziprasidone, Placebo
Keywords: Schizophrenia, Atypical antipsychotic, Psychosis
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IloperidoneDrug
Also called Fanapt®, VYV-683
ZiprasidoneDrug
PlaceboDrug

Study groups in NCT00254202
Study group	Role	What they receive
Iloperidone	Experimental	Oral iloperidone Receives: Drug: Iloperidone
Ziprasidone	Active comparator	Oral ziprasidone Receives: Drug: Ziprasidone
Placebo	Placebo comparator	Oral placebo Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.
Measured: 4 weeks

Timeline

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

18 Nov 200521 Mar 2007

First posted15 Nov 2005 (estimated)
Study start18 Nov 2005
Primary completion26 Sep 2006
Study completion21 Mar 2007

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 (2)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 593 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00254202
Sponsor's protocol ID: VP-VYV-683-3101
Status last verified: Sep 2026
First submitted: 10 Nov 2005
Last updated: 6 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Cutler AJ, Kalali AH, Weiden PJ, Hamilton J, Wolfgang CD. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008 Apr;28(2 Suppl 1):S20-8. doi: 10.1097/JCP.0b013e318169d4ce.
PubMed 18334909
Volpi S, Potkin SG, Malhotra AK, Licamele L, Lavedan C. Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia. J Clin Psychiatry. 2009 Jun;70(6):801-9. doi: 10.4088/jcp.08m04391.
PubMed 19573479

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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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.
ClinicalTrials.gov ID: NCT00254202
Acronym / sponsor ID: VP-VYV-683-3101
Conditions: Schizophrenia
Keywords: Schizophrenia, Atypical antipsychotic, Psychosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 593 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 18 Nov 2005 (actual)
Primary completion: 26 Sep 2006 (actual)
Study completion: 21 Mar 2007 (actual)
First posted: 15 Nov 2005 (estimated)
Results: Posted 13 Dec 2024

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 determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Detailed description

Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Iloperidone	Experimental	Drug: IloperidoneOral iloperidone
Ziprasidone	Active comparator	Drug: ZiprasidoneOral ziprasidone
Placebo	Placebo comparator	Drug: PlaceboOral placebo

Who may qualify

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

Key inclusion criteria (2 listed)

DSM-IV diagnosis of schizophrenia
PANSS-T of at least 70 at screening and baseline

Key exclusion criteria (2 listed)

Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
DSM-IV diagnosis of psychiatric disorder other than schizophrenia

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
IloperidoneAlso: Fanapt®, VYV-683	Drug	Iloperidone
Ziprasidone	Drug	Ziprasidone
Placebo	Drug	Placebo

Primary outcome

Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score
Time frame: 4 weeks
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.

Results and safety

Results posted to the registry on 13 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iloperidone	295	193
Ziprasidone	149	98
Placebo	149	90

Primary outcome: Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score

Time frame: 4 weeks. Mean (Standard Error). Unit: score on a scale

Measure	Iloperidone n = 283	Ziprasidone n = 144	Placebo n = 140
Value	-12.0 (1.03)	-12.3 (1.44)	-7.1 (1.48)

Population analysed: The modified Intent-to-Treat (ITT) population comprise all randomized patients who receive at least one dose of study medication in the short-term double-blind phase and for whom a baseline PANSS score measurement is obtained and at least one post-baseline PANSS score measurement is obtained while on study medication. For patients randomized in error at a second site after being randomized once, the data from the second site were excluded from analysis in the modified ITT population.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iloperidone	2 of 300 (0.7%)	221 of 300 (73.7%)	0 of 300
Ziprasidone	2 of 150 (1.3%)	118 of 150 (78.7%)	0 of 150
Placebo	5 of 147 (3.4%)	86 of 147 (58.5%)	0 of 147

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18334909Cutler AJ, Kalali AH, Weiden PJ, Hamilton J, Wolfgang CD. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008 Apr;28(2 Suppl 1):S20-8. doi: 10.1097/JCP.0b013e318169d4ce.
Derived from this study: PubMed 19573479Volpi S, Potkin SG, Malhotra AK, Licamele L, Lavedan C. Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia. J Clin Psychiatry. 2009 Jun;70(6):801-9. doi: 10.4088/jcp.08m04391.

Related trials for Schizophrenia

Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
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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.

The record lists no contact. Use the official record to reach the sponsor.

42 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Iloperidone and Ziprasidone in people with Schizophrenia, run by Vanda Pharmaceuticals at 42 sites in 2 countries.

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 2 inclusion and 2 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Dec 2024). 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 in Positive and Negative Symptom Scale Total (PANSS-T) Score (time frame: 4 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 NCT00254202, which also lists 2 linked publications.

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 6 Oct 2026.