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Risperidone Maintenance Treatment in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00848432
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 24, 2009
Sponsor:
Information provided by:
Capital Medical University

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).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: risperidone Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia
Study Start Date : December 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. relapse [ Time Frame: at least one year ]

Secondary Outcome Measures :
  1. psychopathology; extrapyramidal side effects and other adverse events [ Time Frame: at least one year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents