Schizophrenia, Iloperidone, Efficacy
Conditions
Keywords
schizophrenia, iloperidone, Risperidone, Efficacy, Safety
Brief summary
The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.
Interventions
DRUGiloperidone
Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.
DRUGRisperidone
Risperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes.
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men or women ages 18-65 years old. * DSM-IV diagnosis of schizophrenia. * PANSS≥70. * Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points. * Written informed consent.
Exclusion criteria
* Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study. * Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Symptom Scale(PANSS)-Total Score | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Effective percentage(PANSS score reduce rate≥50%) | 6 weeks |
| Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P) | 6 weeks |
| Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N) | 6 weeks |
| Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP) | 6 weeks |
Countries
China
Outcome results
None listed