Schizophrenia
Conditions
Keywords
Schizophrenia, Atypical antipsychotic, Psychosis
Brief 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.
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.
Interventions
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV diagnosis of schizophrenia * PANSS-T of at least 70 at screening and baseline
Exclusion criteria
* Clinically significant disease of the heart, kidneys, liver or gastrointestinal system * DSM-IV diagnosis of psychiatric disorder other than schizophrenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score | 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. |
Countries
India, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iloperidone Oral iloperidone | 295 |
| Ziprasidone Oral ziprasidone | 149 |
| Placebo Oral placebo | 149 |
| Total | 593 |
Baseline characteristics
| Characteristic | Iloperidone | Ziprasidone | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 10.4 | 40.0 years STANDARD_DEVIATION 9.9 | 40.7 years STANDARD_DEVIATION 10.4 | 39.9 years STANDARD_DEVIATION 10.3 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 25 Participants | 12 Participants | 15 Participants | 52 Participants |
| Race/Ethnicity, Customized Black or African American | 147 Participants | 76 Participants | 76 Participants | 299 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 10 Participants | 11 Participants | 29 Participants |
| Race/Ethnicity, Customized White | 111 Participants | 51 Participants | 46 Participants | 208 Participants |
| Sex: Female, Male Female | 50 Participants | 36 Participants | 35 Participants | 121 Participants |
| Sex: Female, Male Male | 245 Participants | 113 Participants | 114 Participants | 472 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 300 | 0 / 150 | 0 / 147 |
| other Total, other adverse events | 221 / 300 | 118 / 150 | 86 / 147 |
| serious Total, serious adverse events | 2 / 300 | 2 / 150 | 5 / 147 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloperidone | Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score | -12.0 score on a scale | Standard Error 1.03 |
| Ziprasidone | Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score | -12.3 score on a scale | Standard Error 1.44 |
| Placebo | Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score | -7.1 score on a scale | Standard Error 1.48 |