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

NCT00859872 | Completed Phase 4 DMC

• 1 other identifier: IIS-0801
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia

Keywords

acute psychotic agitation; schizophrenia; risperidone oral solution; clonazepam; haloperidol

Outcome Measures

Primary Outcomes (1)

• the change of PANSS-EC scores

  5 days

Secondary Outcomes (1)

• response rate based on the PANSS

  47 days

Study Arms (2)

oral group

EXPERIMENTAL

risperidone oral solution combination clonazepam oral

Drug: risperidone oral solution

IM group

ACTIVE COMPARATOR

haloperidol IM injection

Drug: haloperidol

Interventions

risperidone oral solution DRUG

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

oral group

haloperidol DRUG

haloperidol IM injection (5-20mg/d)

IM group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women aged 18 to 45 years
• DSM-IV diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
• A score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the PNASS
• The total scores ≥60 on the PANSS

You may not qualify if:

• Women who are pregnant or breast feeding, or who plan to become pregnant during the study
• The psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
• Clinical laboratory values indicating serious medical illness
• Known hypersensitivity to any of the study medications
• Treatment with a depot antipsychotic with 1 cycle of screening
• Using of disallowed medication

Sponsors & Collaborators

• Central South University: lead
• Wuhan Mental Health Institute: collaborator
• Capital Medical University: collaborator
• Shanghai Mental Health Center: collaborator
• Guangzhou Mental Hospital: collaborator
• Chongqing Mental Hospital: collaborator

Study Sites (1)

MentalHealth Institute of the 2nd Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07

Locations

CN (1)