Quality of Life (QOL) in Female Patient With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Keywords

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Quality of Life Schizophrenia Quetiapine Risperidone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Inje University, Busan Paik Hospital

Principal Investigators

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Joo-Cheol Shim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Center, Paik hospital

Locations

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Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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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. doi: 10.4088/jcp.v67n0909.

Reference Type BACKGROUND

PMID: 17017825 (View on PubMed)

Other Identifiers

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QOL Study 2007

Identifier Type: -

Identifier Source: org_study_id