Risperidone Maintenance Treatment in Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00848432
First received: February 19, 2009
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

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).


Condition Intervention Phase
Schizophrenia
Drug: risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • relapse [ Time Frame: at least one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • psychopathology; extrapyramidal side effects and other adverse events [ Time Frame: at least one year ] [ Designated as safety issue: Yes ]

Enrollment: 404
Study Start Date: December 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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)
Other Name: Risperdal
Experimental: 2
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
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)
Other Name: Risperdal
Experimental: 3
Optimal therapeutic doses of risperidone continued for at least 1 year in clinically stable schizophrenia patients
Drug: risperidone
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)
Other Name: Risperdal

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848432

Locations
China
Beijing Anding Hospital of Capital Medical University
Beijing, China, 100088
Sponsors and Collaborators
Capital Medical University
Investigators
Principal Investigator: Chuan-Yue Wang, MD Beijing Anding Hospital of Capital Medical University
  More Information

No publications provided by Capital Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Chuan-Yue Wang, Beijing Anding Hospital of Capital Medical University
ClinicalTrials.gov Identifier: NCT00848432     History of Changes
Other Study ID Numbers: 2004BA720A22
Study First Received: February 19, 2009
Last Updated: February 23, 2009
Health Authority: China: Ministry of Health

Keywords provided by Capital Medical University:
Schizophrenia
Risperidone
Maintenance treatment
Relapse

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 30, 2014