NCT00498004

Quality of Life (QOL) in Female Patient With Schizophrenia

Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Inje University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate clinical and statistical superiority of quetiapine compared to risperidone in Korean version of Heinrich's Quality of Life Scale after 8 weeks trial of drugs.

Detailed description

Prolactin related adverse events are closely related to patient's perception on their illness and quality of life . Poor subjective wellbeing induced by prolactin elevation after antipsychotic drug treatment can complicate the clinical outcomes of treatment.Quetiapine has negligible effects on the elevation of prolactin and does not produce hyperprolactinemia related adverse events such as amenorrhea, galactorrhea that may disturb quality of life in famel patient. In this Randomized, Open Label, 8-week Study, the impact of quetiapine and risperidone on quality of life in female patients with schizophrenia will be compared.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Quetiapine, Risperidone	The dose of quetiapine will be titrated over 4 days to 300mg/day (50mg at day 1, 100mg at day 2, 200mg at day 3 and 300mg at day 4) and thereafter flexible dose will be administered depending on the clinical state. The dose of risperidone will be titrated as following 2mg at day 1 and 4mg at day 4 and thereafter flexible dose will be administered depending on the clinical state. The dosage of drugs should be 400-800mg/day of quetiapine and 4-6mg/day of risperidone between 6 and 8 weeks of trial.

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-07-09
• Last updated: 2008-11-04

Locations

1 site across 1 country: South Korea