search
Back to results

Risperidone Maintenance Treatment in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
risperidone
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Maintenance treatment, Relapse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anding Hospital of Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

relapse

Secondary Outcome Measures

psychopathology; extrapyramidal side effects and other adverse events

Full Information

First Posted
February 19, 2009
Last Updated
February 23, 2009
Sponsor
Capital Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT00848432
Brief Title
Risperidone Maintenance Treatment in Schizophrenia
Official Title
Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Risperidone, Maintenance treatment, Relapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Experimental
Arm Description
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
Arm Title
3
Arm Type
Experimental
Arm Description
Optimal therapeutic doses of risperidone continued for at least 1 year in clinically stable schizophrenia patients
Intervention Type
Drug
Intervention Name(s)
risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
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)
Primary Outcome Measure Information:
Title
relapse
Time Frame
at least one year
Secondary Outcome Measure Information:
Title
psychopathology; extrapyramidal side effects and other adverse events
Time Frame
at least one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuan-Yue Wang, MD
Organizational Affiliation
Beijing Anding Hospital of Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital of Capital Medical University
City
Beijing
ZIP/Postal Code
100088
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33538534
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.
Results Reference
derived
PubMed Identifier
27829454
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.
Results Reference
derived
PubMed Identifier
20231321
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.
Results Reference
derived

Learn more about this trial

Risperidone Maintenance Treatment in Schizophrenia

We'll reach out to this number within 24 hrs