Status:
COMPLETED
Risperidone Maintenance Treatment in Schizophrenia
Lead Sponsor:
Capital Medical University
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 w...
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 schi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00848432
Start Date
December 1 2002
End Date
December 1 2004
Last Update
February 24 2009
Active Locations (1)
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1
Beijing Anding Hospital of Capital Medical University
Beijing, China, 100088