Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623713
• Other study ID #: YPLT20111123
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2012
• Last updated: November 17, 2013
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Efficacy
• Iloperidone
• Schizophrenia

Intervention

Drug:
• iloperidone
Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.
• Risperidone
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.

Locations

Country	Name	City	State
China	Sixth Hospital of Peking University	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. Epub 2005 Sep 19. Erratum in: N Engl J Med. 2010 Sep 9;363(11):1092-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Symptom Scale(PANSS)-Total Score		6 weeks	No
Secondary	Effective percentage(PANSS score reduce rate=50%)		6 weeks	No
Secondary	Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P)		6 weeks	No
Secondary	Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N)		6 weeks	No
Secondary	Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP)		6 weeks	No