Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Schizophrenia Clinical Trial

Official title:

A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00418873
• Other study ID #: LPRIS-0601-TW
• Status: Terminated
• Phase: Phase 4
• First received: January 3, 2007
• Last updated: April 15, 2010
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 65 years, male or female

• In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60.

• Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4

Exclusion Criteria:

• Patients with history of seizure or with alcohol or substance abuse in the last 6 months

• Diabetes, Parkinson's disease or phaeochromocytoma

• Patients with hypertension and current use of antihypertensive agents

• Women who are pregnant, lactating or intend to become pregnant during the study period

• Poor response to two different antipsychotics in full dose and full course or use of clozapine previously

• Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Zotepine
Oral
• Risperidone
Oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.		6 Weeks	No
Secondary	Change from baseline on the total score of Positive and Negative Syndrome Scale		6 Weeks	No
Secondary	Change from baseline on Clinical Global Impression (CGI)		6 Weeks	No