NCT05951660Recruiting
Sex, Psychopharmacology, and Diabetes
The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations. The purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes/prediabetes and/or their healthcare professionals in causes and management of SD: * Increases the number of systematic examinations of sexual side effects, * Causes changes in the psycho-pharmacological treatment, and * Reduces the severity or perception of sexual side effects. The study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions. The study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- First submitted
- 10 Jul 2023
- Start date
- 24 Aug 2023
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Zealand University Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT05951660
What you commit to
- Study type: Interventional
- Planned participants: 256
- From 24 Aug 2023 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Incapacitated or subject to mental health probation
- Unable to speak danish
Who the study is looking for
- Age ≥ 18 years
- A diagnosis in the schizophrenic spectrum (ICD10 F2x)
- One of the following:
- A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)
- 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
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assertive Community Centres Coordinator of this site? Confirm its status | Slagelse | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.