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
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