Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

Schizophrenia Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019887
• Other study ID #: 673
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: January 2017

Study information

• Verified date: August 2021
• Source: Juntendo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Schizophrenia
• Schizophrenia Relapse

Intervention

Drug:
• reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juntendo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Relapse	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.	One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.