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A Survey of Sexual Function in Schizophrenic Patients

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Urogenital Diseases

+ Genital Diseases

+ Sexual Dysfunction, Physiological

From 18 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2009
See protocol details

Summary

Principal SponsorBeth Israel Medical Center
Last updated: August 4, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorBeth Israel Medical Center
Last updated: August 4, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesSexual Dysfunction, Physiological

Criteria

4 inclusion criteria required to participate
Able to participate in a structured interview

Age 18 - 65

Meet DSM-IV diagnostic criteria for Schizophrenia

On stable doses of either one or more antipsychotic medication for at least six weeks

2 exclusion criteria prevent from participating
Patients taking Selective Serotonin Reuptake Inhibitors (SSRIs)

Patients whose ability to provide informed consent is compromised -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Beth Israel Medical Center

New York, United StatesOpen Beth Israel Medical Center in Google Maps
SuspendedOne Study Center