Quality of Life (QOL) in Female Patient With Schizophrenia

• Sponsor: Inje University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00498004
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 7.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Quetiapine, Risperidone	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Outcome Measures

Primary Outcome Measures

1. QOL measured by Korean version of Heinrich's Quality of Life Scale [8weeks]

Secondary Outcome Measures

1. Korean version of Female Sexual Function Index [8 weeks]

2. Korean version of Female Sexual Distress Scale [8 weeks]

3. Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH [8 weeks]

4. Psychopathology (Brief Psychiatric Rating Scale) [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Busan Paik Hospital	Busan		Korea, Republic of	614-735

Sponsors and Collaborators

• Inje University

Investigators

• Principal Investigator: Joo-Cheol Shim, MD,PhD, Clinical Trial Center, Paik hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00498004
• Other Study ID Numbers: QOL Study 2007
• First Posted: Jul 9, 2007
• Last Update Posted: Nov 4, 2008
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: Quality of Life; Schizophrenia; Quetiapine; Risperidone
• Additional relevant MeSH terms: Schizophrenia; Risperidone; Quetiapine Fumarate

Study Results

No Results Posted as of Nov 4, 2008