Risperidone Maintenance Treatment in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-12-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

risperidone

Intervention Type DRUG

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)

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

Group Type EXPERIMENTAL

risperidone

Intervention Type DRUG

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)

3

Optimal therapeutic doses of risperidone continued for at least 1 year in clinically stable schizophrenia patients

Group Type EXPERIMENTAL

risperidone

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Risperdal

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No