Quality of Life (QOL) in Female Patient With Schizophrenia

This study has been terminated.
(difficult to recruit subject)
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00498004
First received: July 6, 2007
Last updated: November 3, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Quetiapine, Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • QOL measured by Korean version of Heinrich's Quality of Life Scale [ Time Frame: 8weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Korean version of Female Sexual Function Index [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Korean version of Female Sexual Distress Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Psychopathology (Brief Psychiatric Rating Scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498004

Locations
Korea, Republic of
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
  More Information

Publications:
Responsible Party: Joo Shim, Inje University, Busan Paik Hospital
ClinicalTrials.gov Identifier: NCT00498004     History of Changes
Other Study ID Numbers: QOL Study 2007
Study First Received: July 6, 2007
Last Updated: November 3, 2008
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Inje University:
Quality of Life
Schizophrenia
Quetiapine
Risperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Quetiapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 16, 2014