Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Zotepine

Group Type EXPERIMENTAL

Zotepine

Intervention Type DRUG

Oral

2. Risperidone

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Oral

Interventions

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Zotepine

Oral

Intervention Type DRUG

Risperidone

Oral

Intervention Type DRUG

Other Intervention Names

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Lodopin® Zoleptil® Nipolept® Risperdal®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No