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Completed

NCT Number: NCT00848432

Risperidone Maintenance Treatment in 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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Anding Hospital of Capital Medical University

Beijing, 100088, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Risperdal

Primary outcomes

  1. relapse

    Time frame: at least one year

Secondary outcomes

  1. psychopathology; extrapyramidal side effects and other adverse events

    Time frame: at least one year

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Risperidone Maintenance Treatment for Relapse Prevention in Schizophrenia

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Feb 20, 2009
Registry last updated
Feb 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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