Quality of Life (QOL) in Female Patient With Schizophrenia

Phase 4

Terminated

• Conditions: Schizophrenia

• Registration Number: NCT00498004
• Lead Sponsor: Inje University

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.

Study Timeline

• Study First Submitted: 2007-07-06
• Study First Submitted QC: 2007-07-06
• Study First Posted: 2007-07-09
• Study Start: 2007-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-03
• Last Update Posted: 2008-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
QOL measured by Korean version of Heinrich's Quality of Life Scale	8weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of