Risperidone Maintenance Treatment in Schizophrenia - Full Text View

Purpose

This study set out to determine the duration of maintenance treatment with therapeutic risperidone dose in schizophrenia. In a multi-center, open label, randomized, controlled study design, patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months).

Condition	Intervention	Phase
Schizophrenia	Drug: risperidone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:

relapse [ Time Frame: at least one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

psychopathology; extrapyramidal side effects and other adverse events [ Time Frame: at least one year ] [ Designated as safety issue: Yes ]

Enrollment:	404
Study Start Date:	December 2002
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Optimal therapeutic doses of risperidone continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months in clinically stable schizophrenia patients	Drug: risperidone Patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months) Other Name: Risperdal
Experimental: 2 Optimal therapeutic doses of risperidone continued for 26 weeks followed by a 50% dose reduction for at least another 6 months in clinically stable schizophrenia patients	Drug: risperidone Patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months) Other Name: Risperdal
Experimental: 3 Optimal therapeutic doses of risperidone continued for at least 1 year in clinically stable schizophrenia patients	Drug: risperidone Patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months) Other Name: Risperdal

Detailed Description:

Prevention of relapse is the crucial task in the maintenance treatment of schizophrenia. This study set out to determine the duration of maintenance treatment with therapeutic risperidone dose in schizophrenia. In a multi-center, open label, randomized, controlled study design, patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

in- or outpatient of either sex diagnosed with DSM-IV schizophrenia
having been clinically stable following an acute episode for at least 4 but less than 8 weeks, with 'clinical stability' defined as a sum score of the Brief Psychiatric Rating Scale (BPRS) of less than 36 points
aged between 18 and 65 years
receiving risperidone monotherapy titrated to optimal level in the acute phase of treatment for the psychotic episode
local resident, living with at least one family member after discharge
having satisfactory treatment adherence defined by a pill count that yielded more than 80% adherence to risperidone prescription over the past 4 weeks
understanding the aims of the study and having signed the consent form

Exclusion Criteria:

taking antidepressants, mood stabilizers, and Chinese herbal remedies concomitantly with risperidone, or having received electroconvulsive therapy (ECT), or participating in any other drug trials or interventional studies over the 4 weeks before study entry
having a history or ongoing experience of major chronic medical or neurological condition(s) requiring treatment that would be likely to affect psychic functions
past or current drug/alcohol abuse other than nicotine
being pregnant or having plans to become pregnant, lactating, or not practicing an effective method of birth control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848432

Locations

China
Beijing Anding Hospital of Capital Medical University
Beijing, China, 100088

Sponsors and Collaborators

Capital Medical University

Investigators

Principal Investigator:

Chuan-Yue Wang, MD

Beijing Anding Hospital of Capital Medical University

More Information

No publications provided by Capital Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang CY, Xiang YT, Cai ZJ, Weng YZ, Bo QJ, Zhao JP, Liu TQ, Wang GH, Weng SM, Zhang HY, Chen DF, Tang WK, Ungvari GS; Risperidone Maintenance Treatment in Schizophrenia (RMTS) investigators. Risperidone maintenance treatment in schizophrenia: a randomized, controlled trial. Am J Psychiatry. 2010 Jun;167(6):676-85. Epub 2010 Mar 15.

Responsible Party:	Professor Chuan-Yue Wang, Beijing Anding Hospital of Capital Medical University
ClinicalTrials.gov Identifier:	NCT00848432 History of Changes
Other Study ID Numbers:	2004BA720A22
Study First Received:	February 19, 2009
Last Updated:	February 23, 2009
Health Authority:	China: Ministry of Health

Keywords provided by Capital Medical University:

Schizophrenia
Risperidone
Maintenance treatment
Relapse

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 21, 2013