| NCT ID | NCT05951660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2023-08-24 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Gesche Jürgens, Clinical Professor
STUDY CHAIR
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Frequently Asked Questions
Who can join the NCT05951660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05951660 currently recruiting?
Yes, NCT05951660 is actively recruiting participants. Contact the research team at gju@regionsjaelland.dk for enrollment information.
Where is the NCT05951660 trial being conducted?
This trial is being conducted at Slagelse, Denmark.
Who is sponsoring the NCT05951660 clinical trial?
NCT05951660 is sponsored by Zealand University Hospital. The principal investigator is Gesche Jürgens, Clinical Professor at Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark. The trial plans to enroll 256 participants.
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