Back to resultsQuality of Life (QOL) in Female Patient With Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quetiapine, Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Quality of Life, Schizophrenia, Quetiapine, Risperidone
Eligibility Criteria
Inclusion Criteria:
- Diagnosis: Schizophrenia (DSM-IV)
- Female, Age: between 18-60 years
- Who either need first time treatment with antipsychotic drug or recently
- Sign written informed consent
Exclusion Criteria:
- Taking other psychiatric medications during last 30 days
- Refractory schizophrenia
- A current medical illness associated with sexual dysfunction
- Previous history of no response to quetiapine or risperidone treatment
- Previous enrolment or randomisation of treatment in the present study.
- Participation in a clinical study during the last 90 days.
- Pregnancy
- Alcohol or substance abuser
Sites / Locations
- Busan Paik Hospital
Outcomes
Primary Outcome Measures
QOL measured by Korean version of Heinrich's Quality of Life Scale
Secondary Outcome Measures
Korean version of Female Sexual Function Index
Korean version of Female Sexual Distress Scale
Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH
Psychopathology (Brief Psychiatric Rating Scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00498004
Brief Title
Quality of Life (QOL) in Female Patient With Schizophrenia
Official Title
Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Terminated
Why Stopped
difficult to recruit subject
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Inje University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Quality of Life, Schizophrenia, Quetiapine, Risperidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine, Risperidone
Intervention Description
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.
Primary Outcome Measure Information:
Title
QOL measured by Korean version of Heinrich's Quality of Life Scale
Time Frame
8weeks
Secondary Outcome Measure Information:
Title
Korean version of Female Sexual Function Index
Time Frame
8 weeks
Title
Korean version of Female Sexual Distress Scale
Time Frame
8 weeks
Title
Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH
Time Frame
8 weeks
Title
Psychopathology (Brief Psychiatric Rating Scale)
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis: Schizophrenia (DSM-IV)
Female, Age: between 18-60 years
Who either need first time treatment with antipsychotic drug or recently
Sign written informed consent
Exclusion Criteria:
Taking other psychiatric medications during last 30 days
Refractory schizophrenia
A current medical illness associated with sexual dysfunction
Previous history of no response to quetiapine or risperidone treatment
Previous enrolment or randomisation of treatment in the present study.
Participation in a clinical study during the last 90 days.
Pregnancy
Alcohol or substance abuser
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Cheol Shim, MD,PhD
Organizational Affiliation
Clinical Trial Center, Paik hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Busan Paik Hospital
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
17017825
Citation
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.
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Quality of Life (QOL) in Female Patient With Schizophrenia
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