A Survey of Sexual Function in Schizophrenic Patients
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 27, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 4, 2015
August 1, 2015
5 years
March 27, 2013
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Level of sexual functioning
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.
4 weeks
Eligibility Criteria
Beth Israel Medical Center outpatient behavioral and mental health clinic
You may qualify if:
- Age 18 - 65
- Able to participate in a structured interview
- Meet DSM-IV diagnostic criteria for Schizophrenia
- On stable doses of either one or more antipsychotic medication for at least six weeks
You may not qualify if:
- Patients taking Selective Serotonin Reuptake Inhibitors (SSRIs)
- Patients whose ability to provide informed consent is compromised -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Medical Center
New York, New York, 10003, United States
Related Publications (9)
Aizenberg D, Modai I, Landa A, Gil-Ad I, Weizman A. Comparison of sexual dysfunction in male schizophrenic patients maintained on treatment with classical antipsychotics versus clozapine. J Clin Psychiatry. 2001 Jul;62(7):541-4. doi: 10.4088/jcp.v62n07a07.
PMID: 11488365RESULTAizenberg D, Zemishlany Z, Dorfman-Etrog P, Weizman A. Sexual dysfunction in male schizophrenic patients. J Clin Psychiatry. 1995 Apr;56(4):137-41.
PMID: 7713851RESULTByerly MJ, Lescouflair E, Weber MT, Bugno RM, Fisher R, Carmody T, Varghese F, Rush AJ. An open-label trial of quetiapine for antipsychotic-induced sexual dysfunction. J Sex Marital Ther. 2004 Oct-Dec;30(5):325-32. doi: 10.1080/00926230490465082.
PMID: 15672600RESULTByerly MJ, Nakonezny PA, Rush AJ. Sexual functioning associated with quetiapine switch vs. risperidone continuation in outpatients with schizophrenia or schizoaffective disorder: a randomized double-blind pilot trial. Psychiatry Res. 2008 May 30;159(1-2):115-20. doi: 10.1016/j.psychres.2007.02.014. Epub 2008 Mar 4.
PMID: 18295343RESULTFan X, Henderson DC, Chiang E, Briggs LB, Freudenreich O, Evins AE, Cather C, Goff DC. Sexual functioning, psychopathology and quality of life in patients with schizophrenia. Schizophr Res. 2007 Aug;94(1-3):119-27. doi: 10.1016/j.schres.2007.04.033. Epub 2007 Jun 22.
PMID: 17590315RESULTHanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.
PMID: 19102734RESULTKelly DL, Conley RR. A randomized double-blind 12-week study of quetiapine, risperidone or fluphenazine on sexual functioning in people with schizophrenia. Psychoneuroendocrinology. 2006 Apr;31(3):340-6. doi: 10.1016/j.psyneuen.2005.08.010. Epub 2005 Sep 28.
PMID: 16198059RESULTMacdonald S, Halliday J, MacEWAN T, Sharkey V, Farrington S, Wall S, McCreadie RG. Nithsdale Schizophrenia Surveys 24: sexual dysfunction. Case-control study. Br J Psychiatry. 2003 Jan;182:50-6. doi: 10.1192/bjp.182.1.50.
PMID: 12509318RESULTWirshing DA, Pierre JM, Marder SR, Saunders CS, Wirshing WC. Sexual side effects of novel antipsychotic medications. Schizophr Res. 2002 Jul 1;56(1-2):25-30. doi: 10.1016/s0920-9964(01)00271-7.
PMID: 12084416RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Lin, MD
Beth Israel Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 19, 2013
Study Start
July 1, 2009
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 4, 2015
Record last verified: 2015-08