Quality of Life (QOL) in Female Patient With Schizophrenia

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Quetiapine, Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis: Schizophrenia (DSM-IV) Female, Age: between 18-60 years Who either need first time treatment with antipsychotic drug or recently Sign written informed consent Exclusion Criteria: Taking other psychiatric medications during last 30 days Refractory schizophrenia A current medical illness associated with sexual dysfunction Previous history of no response to quetiapine or risperidone treatment Previous enrolment or randomisation of treatment in the present study. Participation in a clinical study during the last 90 days. Pregnancy Alcohol or substance abuser

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL measured by Korean version of Heinrich's Quality of Life Scale |  | 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean version of Female Sexual Function Index |  | 8 weeks | 
| Korean version of Female Sexual Distress Scale |  | 8 weeks | 
| Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH |  | 8 weeks | 
| Psychopathology (Brief Psychiatric Rating Scale) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Schizophrenia, Quetiapine, Risperidone