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Risperidone Maintenance Treatment in Schizophrenia

Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: risperidone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Capital Medical University

Official(s) and/or principal investigator(s):
Chuan-Yue Wang, MD, Principal Investigator, Affiliation: Beijing Anding Hospital of Capital Medical University

Summary

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).

Clinical Details

Official title: Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: relapse

Secondary outcome: psychopathology; extrapyramidal side effects and other adverse events

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. in- or outpatient of either sex diagnosed with DSM-IV schizophrenia 2. 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 3. aged between 18 and 65 years 4. receiving risperidone monotherapy titrated to optimal level in the acute phase of treatment for the psychotic episode 5. local resident, living with at least one family member after discharge 6. having satisfactory treatment adherence defined by a pill count that yielded more than 80% adherence to risperidone prescription over the past 4 weeks 7. understanding the aims of the study and having signed the consent form Exclusion Criteria: 1. 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 2. having a history or ongoing experience of major chronic medical or neurological condition(s) requiring treatment that would be likely to affect psychic functions 3. past or current drug/alcohol abuse other than nicotine 4. being pregnant or having plans to become pregnant, lactating, or not practicing an effective method of birth control

Locations and Contacts

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

Starting date: December 2002
Last updated: February 23, 2009

Page last updated: August 23, 2015

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