Sexual DysfunctionNCT01835522
A Survey of Sexual Function in Schizophrenic Patients
An observational study of Sexual Dysfunction, run by Beth Israel Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sexual Dysfunction
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Beth Israel Medical Center outpatient behavioral and mental health clinic
Who may be able to join
- 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
Who cannot join
- Patients taking Selective Serotonin Reuptake Inhibitors (SSRIs)
- Patients whose ability to provide informed consent is compromised -
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
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.
Read the detailed description
OBJECTIVE 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.
BACKGROUND AND SIGNIFICANCE Schizophrenia The Diagnostic and Statistical Manual of Mental Disorders (4th Edition) classifies Schizophrenia as an AXIS I disorder with psychosis as the prominent aspect of its presentation. The essential features of Schizophrenia are a mixture of characteristic signs and symptoms that have been present for a significant portion of time during a 1-month period, with some signs of the disorder persisting for at least 6 months, and are associated with significant social or occupational dysfunction. Characteristic symptoms include delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behavior, and negative symptoms, such as flattening of affect, alogia, and/or avolition. The prevalence of schizophrenia has been estimated in the range of 0.5%-1.5%, and has been observed in all societies and geographical areas, and incidence and prevalence rates are roughly equal worldwide. The median age of onset is typically between late-teens and early 30s, although is most commonly diagnosed in a person's 20s. The course may be variable. Some patients experience exacerbations and remissions, whereas other patients remain chronically ill, some stable, others displaying progressive worsening.
Antipsychotic Medication Two major classes of medications are used to treat Schizophrenia and other psychotic disorders, dopamine receptor antagonists (typical antipsychotics) and serotonin-dopamine antagonists (atypical antipsychotics). While both classes are efficacious, the atypicals are associated with fewer neurological adverse effects, and are effective against a broader range of psychotic symptoms. Most dopamine receptor antagonists have significant effects on other types of receptors, including adrenergic, cholinergic, and histaminergic receptors. Effects on sexual function are mediated primarily through the resulting imbalances in adrenergic and cholinergic activities, decreases in catecholamine activity, and endocrine effects. Blockade of the dopamine receptors in the tuberoinfundibular tract results in the increased secretion of prolactin, which can result in breast enlargement, galactorrhea, impotence in men, and amenorrhea and inhibited orgasm in women. The incidence of these effects is believed to be significantly underestimated. Up to 50% of men taking dopamine blockers may experience ejaculatory and erectile dysfunction. Both men and women can experience anorgasmia and decreased libido.
Treatment Studies Sexual dysfunction is prevalent among psychiatric patients in general, and may be related to both psychopathology and pharmacotherapy. There have been many studies that highlight the problems with sexual functioning experienced by patients with schizophrenia. One study which used a self-completed gender-specific questionnaire revealed that 82% of men and 96% of women with schizophrenia reported at least one sexual dysfunction. As unwanted side effects often play the most significant role in medication non-compliance, on-going research in these areas remains necessary. A number of studies have addressed the issue of sexual function and schizophrenia. One study found that patients with untreated schizophrenia exhibit decreased sexual desire. Treatment with neuroleptics was associated with restoration of sexual desire; however, it created erectile, orgasmic, and sexual satisfaction problems. It was clear that more research was needed. Multiple studies have been conducted which have shown that antipsychotic medications, both typicals and atypicals, contribute to alterations in prolactin levels. Some studies were able to correlate changes in prolactin levels to problems with sexual function, however, other studies have shown that while antipsychotics do alter prolactin levels, they are not always specifically correlated to improvements in sexual side effects or self-reported sexual dysfunction. However, the majority of the aforementioned studies focused solely on laboratory markers (prolactin and other reproductive hormones), have compared only one drug to another, and/or studied men only. The majority of these studies that did use a self-report measure of sexual dysfunction used the Arizona Sexual Experience Scale, a 5 item scale, which may not be inclusive enough to fully assess the full scope of sexual dysfunction. One study, similar in design to this proposed study, did compare multiple agents in both men and women, used the CSFQ for assessment of sexual function and controlled for severity of illness. The study found that high rates of sexual impairment were found in both male and female patients. For males, higher scores on the PANSS-positive subscale were associated with a lower frequency of sexual activity. For females, higher scores on the PANSS - positive subscale and PANSS- general psychopathology subscale were significantly associated with more difficulty in both sexual arousal and orgasm. Interestingly, no significant differences were found between medication groups. However, of the 124 patients enrolled in the study, only 69% (84 subjects) completed at least part of the CSFQ assessment. Meaning even less completed the entire questionnaire.
GOAL AND HYPOTHESES The current study aims to study the relationship between self-reported sexual dysfunction in both men and women diagnosed with schizophrenia, treatment with antipsychotic medication, and disease severity.
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.
- Conditions
- Sexual Dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startJul 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sexual Medicine Society of North America
- Responsible party
- Sponsor
- Investigators
- Dennis Lin, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835522
- Sponsor's protocol ID
- Beth_IsraelMC 058-09
- Status last verified
- Aug 2015
- First submitted
- 27 Mar 2013
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11488365Aizenberg D, Zemishlany Z, Dorfman-Etrog P, Weizman A. Sexual dysfunction in male schizophrenic patients. J Clin Psychiatry. 1995 Apr;56(4):137-41.
PubMed 7713851Byerly 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.
PubMed 15672600Byerly 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.
PubMed 18295343Fan 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.
PubMed 17590315Hanssens 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.
PubMed 19102734Kelly 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.
PubMed 16198059Macdonald 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.
PubMed 12509318Wirshing 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.
PubMed 12084416
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Sexual Function in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT01835522
- Acronym / sponsor ID
- Beth_IsraelMC 058-09
- Conditions
- Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Collaborators
- Sexual Medicine Society of North America
- Study start
- Jul 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVE 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.
BACKGROUND AND SIGNIFICANCE Schizophrenia The Diagnostic and Statistical Manual of Mental Disorders (4th Edition) classifies Schizophrenia as an AXIS I disorder with psychosis as the prominent aspect of its presentation. The essential features of Schizophrenia are a mixture of characteristic signs and symptoms that have been present for a significant portion of time during a 1-month period, with some signs of the disorder persisting for at least 6 months, and are associated with significant social or occupational dysfunction. Characteristic symptoms include delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behavior, and negative symptoms, such as flattening of affect, alogia, and/or avolition. The prevalence of schizophrenia has been estimated in the range of 0.5%-1.5%, and has been observed in all societies and geographical areas, and incidence and prevalence rates are roughly equal worldwide. The median age of onset is typically between late-teens and early 30s, although is most commonly diagnosed in a person's 20s. The course may be variable. Some patients experience exacerbations and remissions, whereas other patients remain chronically ill, some stable, others displaying progressive worsening.
Antipsychotic Medication Two major classes of medications are used to treat Schizophrenia and other psychotic disorders, dopamine receptor antagonists (typical antipsychotics) and serotonin-dopamine antagonists (atypical antipsychotics). While both classes are efficacious, the atypicals are associated with fewer neurological adverse effects, and are effective against a broader range of psychotic symptoms. Most dopamine receptor antagonists have significant effects on other types of receptors, including adrenergic, cholinergic, and histaminergic receptors. Effects on sexual function are mediated primarily through the resulting imbalances in adrenergic and cholinergic activities, decreases in catecholamine activity, and endocrine effects. Blockade of the dopamine receptors in the tuberoinfundibular tract results in the increased secretion of prolactin, which can result in breast enlargement, galactorrhea, impotence in men, and amenorrhea and inhibited orgasm in women. The incidence of these effects is believed to be significantly underestimated. Up to 50% of men taking dopamine blockers may experience ejaculatory and erectile dysfunction. Both men and women can experience anorgasmia and decreased libido.
Treatment Studies Sexual dysfunction is prevalent among psychiatric patients in general, and may be related to both psychopathology and pharmacotherapy. There have been many studies that highlight the problems with sexual functioning experienced by patients with schizophrenia. One study which used a self-completed gender-specific questionnaire revealed that 82% of men and 96% of women with schizophrenia reported at least one sexual dysfunction. As unwanted side effects often play the most significant role in medication non-compliance, on-going research in these areas remains necessary. A number of studies have addressed the issue of sexual function and schizophrenia. One study found that patients with untreated schizophrenia exhibit decreased sexual desire. Treatment with neuroleptics was associated with restoration of sexual desire; however, it created erectile, orgasmic, and sexual satisfaction problems. It was clear that more research was needed. Multiple studies have been conducted which have shown that antipsychotic medications, both typicals and atypicals, contribute to alterations in prolactin levels. Some studies were able to correlate changes in prolactin levels to problems with sexual function, however, other studies have shown that while antipsychotics do alter prolactin levels, they are not always specifically correlated to improvements in sexual side effects or self-reported sexual dysfunction. However, the majority of the aforementioned studies focused solely on laboratory markers (prolactin and other reproductive hormones), have compared only one drug to another, and/or studied men only. The majority of these studies that did use a self-report measure of sexual dysfunction used the Arizona Sexual Experience Scale, a 5 item scale, which may not be inclusive enough to fully assess the full scope of sexual dysfunction. One study, similar in design to this proposed study, did compare multiple agents in both men and women, used the CSFQ for assessment of sexual function and controlled for severity of illness. The study found that high rates of sexual impairment were found in both male and female patients. For males, higher scores on the PANSS-positive subscale were associated with a lower frequency of sexual activity. For females, higher scores on the PANSS - positive subscale and PANSS- general psychopathology subscale were significantly associated with more difficulty in both sexual arousal and orgasm. Interestingly, no significant differences were found between medication groups. However, of the 124 patients enrolled in the study, only 69% (84 subjects) completed at least part of the CSFQ assessment. Meaning even less completed the entire questionnaire.
GOAL AND HYPOTHESES The current study aims to study the relationship between self-reported sexual dysfunction in both men and women diagnosed with schizophrenia, treatment with antipsychotic medication, and disease severity.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Beth Israel Medical Center outpatient behavioral and mental health clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients taking Selective Serotonin Reuptake Inhibitors (SSRIs)
- Patients whose ability to provide informed consent is compromised -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of sexual functioning
Time frame: 4 weeks
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Results publication: PubMed 11488365Aizenberg 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.
- Results publication: PubMed 7713851Aizenberg D, Zemishlany Z, Dorfman-Etrog P, Weizman A. Sexual dysfunction in male schizophrenic patients. J Clin Psychiatry. 1995 Apr;56(4):137-41.
- Results publication: PubMed 15672600Byerly 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.
- Results publication: PubMed 18295343Byerly 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.
- Results publication: PubMed 17590315Fan 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.
- Results publication: PubMed 19102734Hanssens 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.
- Results publication: PubMed 16198059Kelly 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.
- Results publication: PubMed 12509318Macdonald 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.
- Results publication: PubMed 12084416Wirshing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Lin, MD principal investigator
Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction, run by Beth Israel Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of sexual functioning (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01835522, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.