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Quality of Life (QOL) in Female Patient With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00498004
Recruitment Status : Terminated (difficult to recruit subject)
First Posted : July 9, 2007
Last Update Posted : November 4, 2008
Information provided by:

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  (Clinical Trial)
Estimated 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 : August 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. QOL measured by Korean version of Heinrich's Quality of Life Scale [ Time Frame: 8weeks ]

Secondary Outcome Measures :
  1. Korean version of Female Sexual Function Index [ Time Frame: 8 weeks ]
  2. Korean version of Female Sexual Distress Scale [ Time Frame: 8 weeks ]
  3. Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH [ Time Frame: 8 weeks ]
  4. Psychopathology (Brief Psychiatric Rating Scale) [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498004

Korea, Republic of
Busan Paik Hospital
Busan, Korea, Republic of, 614-735
Sponsors and Collaborators
Inje University
Principal Investigator: Joo-Cheol Shim, MD,PhD Clinical Trial Center, Paik hospital
More Information

Responsible Party: Joo Shim, Inje University, Busan Paik Hospital
ClinicalTrials.gov Identifier: NCT00498004     History of Changes
Other Study ID Numbers: QOL Study 2007
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: November 4, 2008
Last Verified: November 2008

Keywords provided by Inje University:
Quality of Life

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents