Schizophrenia
Conditions
Keywords
Quality of Life, Schizophrenia, Quetiapine, Risperidone
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.
Interventions
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.
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis: Schizophrenia (DSM-IV) 2. Female, Age: between 18-60 years 3. Who either need first time treatment with antipsychotic drug or recently 4. Sign written informed consent
Exclusion criteria
1. Taking other psychiatric medications during last 30 days 2. Refractory schizophrenia 3. A current medical illness associated with sexual dysfunction 4. Previous history of no response to quetiapine or risperidone treatment 5. Previous enrolment or randomisation of treatment in the present study. 6. Participation in a clinical study during the last 90 days. 7. Pregnancy 8. Alcohol or substance abuser
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL measured by Korean version of Heinrich's Quality of Life Scale | 8weeks |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed