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Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia

NCT00859872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2009-08-03

No results posted yet for this study

Summary

This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study.

After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.

Conditions

Interventions

DRUG

risperidone oral solution

risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral

DRUG

haloperidol

haloperidol IM injection (5-20mg/d)

Sponsors & Collaborators

  • Wuhan Mental Health Institute

    collaborator UNKNOWN

  • Capital Medical University

    collaborator OTHER

  • Shanghai Mental Health Center

    collaborator OTHER

  • Guangzhou Mental Hospital

    collaborator OTHER

  • Chongqing Mental Hospital

    collaborator UNKNOWN

  • Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859872 on ClinicalTrials.gov