Quality of Life (QOL) in Female Patient With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00498004
• Other study ID #: QOL Study 2007
• Status: Terminated
• Phase: Phase 4
• First received: July 6, 2007
• Last updated: November 3, 2008
• Start date: August 2007
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Jung DU, Conley RR, Kelly DL, Kim DW, Yoon SH, Jang JH, Shin JG, Shim JC. Prevalence of bone mineral density loss in Korean patients with schizophrenia: a cross-sectional study. J Clin Psychiatry. 2006 Sep;67(9):1391-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QOL measured by Korean version of Heinrich's Quality of Life Scale		8weeks	Yes
Secondary	Korean version of Female Sexual Function Index		8 weeks	Yes
Secondary	Korean version of Female Sexual Distress Scale		8 weeks	Yes
Secondary	Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH		8 weeks	Yes
Secondary	Psychopathology (Brief Psychiatric Rating Scale)		8 weeks	Yes