Clinical trial NCT00848432: Risperidone Maintenance Treatment in Schizophrenia
Official title: Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Maintenance treatment
Relapse
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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).

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 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

Primary outcomes:
measure: relapse
timeFrame: at least one year
Secondary outcomes:
measure: psychopathology; extrapyramidal side effects and other adverse events
timeFrame: at least one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital of Capital Medical University
Study officials:
affiliation: Beijing Anding Hospital of Capital Medical University
name: Chuan-Yue Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bo Q, Xing X, Li T, Mao Z, Zhou F, Wang C. Menstrual Dysfunction in Women With Schizophrenia During Risperidone Maintenance Treatment. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):135-139. doi: 10.1097/JCP.0000000000001344.
citation: Bo Q, Dong F, Li X, Wang Z, Ma X, Wang C. Prolactin related symptoms during risperidone maintenance treatment: results from a prospective, multicenter study of schizophrenia. BMC Psychiatry. 2016 Nov 9;16(1):386. doi: 10.1186/s12888-016-1103-3.
citation: 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. doi: 10.1176/appi.ajp.2009.09030358. Epub 2010 Mar 15.