A Survey of Sexual Function in Schizophrenic Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Sexual Medicine Society of North America
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01835522
First received: March 27, 2013
Last updated: August 3, 2015
Last verified: August 2015
  Purpose

The goal of this study is to survey patients with a diagnosis of schizophrenia to determine if there is a relationship between self-reported sexual function and treatment with antipsychotic medication.

Hypotheses: 1. Patients on typical antipsychotics will rate their sexual function as lower than those on atypical agents. 2. Patients on multiple antipsychotics will rate their sexual function as lower than those on a single agent.


Condition
Sexual Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Survey of Sexual Function in Schizophrenic Patients

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Level of sexual functioning [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Patient's level of sexual functioning will be measured at the time of assessment. Two different scales will be used depending on the gender of the patient.

    IIEF (International Index of Erectile Function Questionnaire for men) will be used for men. This 15-item questionnaire is a brief, multidimensional instrument for assessing the key dimensions of sexual function in men. It assesses male function and quality of life.

    FSFI (Female Sexual Function Index) will be used for women. This 19-item questionnaire is a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women. It assesses female function and quality of life.



Enrollment: 0
Study Start Date: July 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Beth Israel Medical Center outpatient behavioral and mental health clinic

Criteria

Inclusion Criteria:

  1. Age 18 - 65
  2. Able to participate in a structured interview
  3. Meet DSM-IV diagnostic criteria for Schizophrenia
  4. On stable doses of either one or more antipsychotic medication for at least six weeks

Exclusion Criteria:

  1. Patients taking Selective Serotonin Reuptake Inhibitors (SSRIs)
  2. Patients whose ability to provide informed consent is compromised -
  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: NCT01835522

Locations
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Sexual Medicine Society of North America
Investigators
Principal Investigator: Dennis Lin, MD Beth Israel Medical Center
  More Information

Publications:

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01835522     History of Changes
Other Study ID Numbers: Beth_IsraelMC 058-09
Study First Received: March 27, 2013
Last Updated: August 3, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 27, 2015