A Phase 3 interventional study of Iloperidone and Ziprasidone in Schizophrenia, sponsored by Vanda Pharmaceuticals. Completed at 42 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 593 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral iloperidone
Drug: Iloperidone
Oral ziprasidone
Drug: Ziprasidone
Oral placebo
Drug: Placebo
Also known as: Fanapt®, VYV-683
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.
Time frame: 4 weeks
| Milestone | Iloperidone | Ziprasidone | Placebo |
|---|---|---|---|
| Started | 295 | 149 | 149 |
| Safety population | 300 | 150 | 147 |
| Completed | 193 | 98 | 90 |
| Not completed | 102 | 51 | 59 |
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.
| score on a scale | Iloperidone | Ziprasidone | Placebo |
|---|---|---|---|
| Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score | -12.0 ± 1.03 | -12.3 ± 1.44 | -7.1 ± 1.48 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iloperidone | 0/300 (0%) | 2/300 (0.7%) | 221/300 (73.7%) |
| Ziprasidone | 0/150 (0%) | 2/150 (1.3%) | 118/150 (78.7%) |
| Placebo | 0/147 (0%) | 5/147 (3.4%) | 86/147 (58.5%) |
| Event | Iloperidone | Ziprasidone | Placebo |
|---|---|---|---|
| ConvulsionNervous system disorders | 0/300 | 0/150 | 2/147 |
| Psychotic disorderPsychiatric disorders | 1/300 | 2/150 | 0/147 |
| BradycardiaCardiac disorders | 0/300 | 0/150 | 1/147 |
| Chest painGeneral disorders | 0/300 | 0/150 | 1/147 |
| Myocardial infarctionCardiac disorders | 0/300 | 0/150 | 1/147 |
| HyponatremiaMetabolism and nutrition disorders | 0/300 | 0/150 | 1/147 |
| SchizophreniaPsychiatric disorders | 0/300 | 0/150 | 1/147 |
| Microcytic anemiaBlood and lymphatic system disorders | 1/300 | 0/150 | 0/147 |
| Event | Iloperidone | Ziprasidone | Placebo |
|---|---|---|---|
| SedationNervous system disorders | 38/300 | 41/150 | 12/147 |
| HeadacheNervous system disorders | 61/300 | 35/150 | 29/147 |
| DizzinessNervous system disorders | 51/300 | 20/150 | 11/147 |
| NauseaGastrointestinal disorders | 29/300 | 21/150 | 13/147 |
| Weight increasedInvestigations | 34/300 | 7/150 | 3/147 |
| VomitingGastrointestinal disorders | 17/300 | 16/150 | 10/147 |
| DyspepsiaGastrointestinal disorders | 24/300 | 15/150 | 15/147 |
| ConstipationGastrointestinal disorders | 27/300 | 12/150 | 14/147 |
| TachycardiaCardiac disorders | 28/300 | 3/150 | 1/147 |
| Extrapyramidal disorderNervous system disorders | 10/300 | 14/150 | 3/147 |
| Age, Continuous(years) | Iloperidone | Ziprasidone | Placebo | Total |
|---|---|---|---|---|
| Mean | 39.5 ± 10.4 | 40.0 ± 9.9 | 40.7 ± 10.4 | 39.9 ± 10.3 |
| Sex: Female, Male(Participants) | Iloperidone | Ziprasidone | Placebo | Total |
|---|---|---|---|---|
| Female | 50 | 36 | 35 | 121 |
| Male | 245 | 113 | 114 | 472 |
| Race/Ethnicity, Customized(Participants) | Iloperidone | Ziprasidone | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaskan Native | 2 | 0 | 1 | 3 |
| Asian | 25 | 12 | 15 | 52 |
| Black or African American | 147 | 76 | 76 | 299 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 0 | 2 |
| White | 111 | 51 | 46 | 208 |
| Other | 8 | 10 | 11 | 29 |
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanda Pharmaceuticals