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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: risperidone oral solution; Drug: haloperidol

Detailed Description

Acute psychotic agitation is a common problem in many patients with schizophrenia that includes agitation, aggression, excitement and violence. An investigation showed that about 26% psychotic patients were brought to the psychiatric emergency room because of the psychotic agitation symptoms. The primary objective is to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia and schizophrenic-affective disorder.

The secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute 6 weeks treatment from IM injection to oral; (2) to compare the safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • MentalHealth Institute of the 2nd Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral group; risperidone oral solution combination clonazepam oral	Drug: risperidone oral solution; risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral
Active Comparator: IM group; haloperidol IM injection	Drug: haloperidol; haloperidol IM injection (5-20mg/d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change of PANSS-EC scores	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
response rate based on the PANSS	47 days

Collaborators and Investigators

• Sponsor: Central South University
• Collaborators: Shanghai Mental Health Center; Capital Medical University; Guangzhou Mental Hospital; Wuhan Mental Health Institute; Chongqing Mental Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (Estimate): March 11, 2009

Study Record Updates

• Last Update Posted (Estimate): August 3, 2009
• Last Update Submitted That Met QC Criteria: July 31, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: schizophrenia; haloperidol; clonazepam; acute psychotic agitation; risperidone oral solution
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Dyskinesias; Psychomotor Disorders; Schizophrenia; Psychotic Disorders; Psychomotor Agitation; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Anti-Dyskinesia Agents; Risperidone; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: IIS-0801