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OpenTrials
Completed

NCT Number: NCT03019887

Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

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Key information

Conditions

Schizophrenia Relapse

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • inpatients with a diagnosis of schizophrenia, and
  • those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day.

Exclusion criteria

  • mental retardation,
  • substance abuse or dependence,
  • a history of major head trauma,
  • serious medical or neurological disorders, or
  • depot antipsychotic injections within the previous 3 months and electroconvulsive therapy within the previous 6 months

Treatment and study plan

reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine

Drug

Primary outcomes

  1. Number of Participants With Relapse

    Time frame: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.

    The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.

Sponsors and collaborators

Lead sponsor

Juntendo University

Other

Registry information

Official study title

Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
Sep 9, 2021

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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