Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Astellas

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: Zotepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418873

LPRIS-0601-TW

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

1. Zotepine

Experimental group

Treatment:

Drug: Zotepine

2. Risperidone

Active Comparator group

Treatment:

Drug: Risperidone