A Survey of Sexual Function in Schizophrenic Patients

This study is currently recruiting participants.
Verified November 2013 by Beth Israel Medical Center
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: November 19, 2013
Last verified: November 2013
  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.



Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835522

Contacts
Contact: Dennis Lin, MD 212-420-2227 DeLin@chpnet.org
Contact: Carlyn Snyder, MD 212-420-2227

Locations
United States, New York
Beth Israel Medical Center Recruiting
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: November 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014