DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Zotepine (Drug); Risperidone (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Chang-Jer Tsai, Principal Investigator, Affiliation: Taipei City Hospital


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

Clinical Details

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

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

Primary outcome: Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.

Secondary outcome:

Change from baseline on the total score of Positive and Negative Syndrome Scale

Change from baseline on Clinical Global Impression (CGI)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


- 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

Locations and Contacts

Taipei 110, Taiwan

Taipei 114, Taiwan

Taoyuan 330, Taiwan

Bali, Taipei county 249, Taiwan

Additional Information

Starting date: March 2007
Last updated: April 15, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017