Effects of Antipsychotic Reduction on Negative Subjective Experience and Cognitive Function

UMIN ID: UMIN000001834

Registered date:31/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: schizophrenia
• Date of first enrollment: 2009/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Risperidone or olanzapine will be reduced by 12.5% per 2 weeks or 25% per 4 weeks until a total reduction rate reaches 50%. In case a dose reaches 2mg/day (risperidone) or 5mg/day (olanzapine), the reduction will be terminated.
The dose of risperidone or olanzapine will be maintained.

Outcome(s)

• Primary Outcome: 1) Profile of Mood States (POMS) -Brief Form Japanese Version 2) Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
• Secondary Outcome: 1) Subjective Well-being under Neuroleptic drug treatment Short form, Japanese version (SWNS-J) 2) Drug Attitude Inventory (DAI) -10 3) Clinical Global Impression–Schizophrenia (CGI-SCH) 4) Positive and Negative Syndrome Scale (PANSS) 5) Japanese version of the Calgary Depression Scale for Schizophrenics (JCDSS) 6) Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) 7) EuroQoL 8) Japanese version of the Schedule for Assessment of Insight (SAI-J)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: the presence of any significant medical neurological illness

Related Information

• Primary Sponsor: Keio University, School of Medicine
• Source(s) of Monetary Support: none