Risperidone Maintenance Treatment in Schizophrenia

NCT00848432 | Completed Phase 4 DMC

• 1 other identifier: 2004BA720A22
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Maintenance treatment; Relapse

Outcome Measures

Primary Outcomes (1)

• relapse

  at least one year

Secondary Outcomes (1)

• psychopathology; extrapyramidal side effects and other adverse events

  at least one year

Study Arms (3)

1

EXPERIMENTAL

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

Drug: risperidone

2

EXPERIMENTAL

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

Drug: risperidone

3

EXPERIMENTAL

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

Drug: risperidone

Interventions

risperidone 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)

Also known as: Risperdal

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, 100088, China

Location

Related Publications (3)

• 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.

  PMID: 33538534 DERIVED

• 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.

  PMID: 27829454 DERIVED

• 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.

  PMID: 20231321 DERIVED

MeSH Terms

Conditions

Schizophrenia; Recurrence

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chuan-Yue Wang, MD

  Beijing Anding Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: December 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

CN (1)