Quality of Life (QOL) in Female Patient With Schizophrenia

Inje University

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Quetiapine, Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00498004

QOL Study 2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)