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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01623713
Other study ID # YPLT20111123
Secondary ID
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


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
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