Education on sexual dysfunction for patients with schizophrenia and diabetes
Official title: The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.
Run by Zealand University Hospital · NCT05951660 · Data updated 2026-11-12
This study tests whether providing education about sexual dysfunction can help adults with schizophrenia and diabetes feel better about their sexual health while they are on antipsychotic medication.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Slagelse) |
| Status | Recruiting |
| Started | August 24, 2023 |
| Main results expected | July 31, 2025 |
| Study ends | July 31, 2025 |
| Registry record updated | February 11, 2025 |
| Trial ID | NCT05951660 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with a diagnosis of schizophrenia and either diabetes, prediabetes, or obesity, who are currently on antipsychotic medication and experiencing sexual dysfunction.
✕Probably not a fit
Patients who are incapacitated, under mental health probation, or unable to speak Danish will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of targeted education on sexual dysfunction (SD) for patients diagnosed with schizophrenia and diabetes or prediabetes. It aims to increase the systematic examination of sexual side effects, prompt changes in psycho-pharmacological treatment, and reduce the severity or perception of these side effects. The study employs a multicenter randomized controlled trial design to assess the effectiveness of this educational intervention. Participants will include adults currently receiving antipsychotic treatment and experiencing SD.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and treatment adherence for patients suffering from sexual dysfunction related to schizophrenia and diabetes.
How similar studies have gone: While the approach of addressing sexual dysfunction in psychiatric patients is recognized, this specific educational intervention in the context of schizophrenia and diabetes is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * A diagnosis in the schizophrenic spectrum (ICD10 F2x) * One of the following: 1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x) 2. A current or previous prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring 3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg/m2 * Ongoing treatment with at least one antipsychotic agent * A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14) Exclusion Criteria: * Incapacitated or subject to mental health probation * Unable to speak danish
Where it's running
-
Assertive Community Centres
Slagelse, Denmark Recruiting
Study contacts
- Principal investigator: Annamaria Giraldi, Clinical Professor — Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
- Study coordinator: Gesche Jürgens, Clinical Professor
- Email: gju@regionsjaelland.dk
- Phone: +45-93566501
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding early psychosis and its biological markers
This study is trying to find out more about early signs of psychotic disorders like schizophrenia and bipolar disorder by looking at brain scans and other health data from around 320 participants over a year.
-
Detecting immune inflammation and brain changes in schizophrenia
This study looks at how inflammation in the immune system might be linked to schizophrenia by comparing patients with the condition to healthy individuals over three months.
-
Using Lumateperone to improve motivation in patients with schizophrenia and psychosis
This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.
-
Exploring biomarkers for prediabetes and diabetes using MALDI-TOF MS technology
This study is trying to find new markers in blood and urine samples that can help doctors better diagnose prediabetes and diabetes in different groups of people, including pregnant women.
-
Examining the effects of combined therapy for schizophrenia
This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.
-
Observational study on bariatric surgery outcomes
This study looks at how bariatric surgery affects weight loss and related health issues like diabetes in patients over two years after their surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.