Sex, Psychopharmacology, and Diabetes
Launched by ZEALAND UNIVERSITY HOSPITAL · Jul 10, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Sex, Psychopharmacology, and Diabetes," is exploring the relationship between sexual dysfunction and mental health conditions, particularly in patients with schizophrenia who also have diabetes or prediabetes. The study aims to see if educating patients and their healthcare providers about the causes and management of sexual dysfunction can lead to more discussions about this issue, changes in medication if needed, and a better understanding of sexual side effects. By doing this, the researchers hope to improve the overall quality of life for these individuals.
To participate in the study, individuals must be at least 18 years old, diagnosed with schizophrenia, and also have diabetes or prediabetes. They should currently be taking at least one antipsychotic medication and have some concerns about their sexual function. The trial is currently recruiting participants from 16 treatment centers across Denmark, and it will compare those who receive education about sexual dysfunction to those who do not. Participants can expect to engage in discussions about their experiences and may receive guidance on managing their sexual health alongside their mental health treatment.
Gender
ALL
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
About Zealand University Hospital
Zealand University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its extensive expertise in various medical fields to improve patient outcomes and enhance treatment methodologies. With a commitment to rigorous scientific standards and ethical practices, Zealand University Hospital collaborates with multidisciplinary teams to explore new therapies and interventions, contributing significantly to the global body of medical knowledge. Through its state-of-the-art facilities and focus on patient-centered care, the hospital plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Slagelse, , Denmark
Patients applied
Trial Officials
Gesche Jürgens, Clinical Professor
Study Chair
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Annamaria Giraldi, Clinical Professor
Principal Investigator
Sexological Clinic, Psychiatric Centre Copenhagen, Denmark
Lise Tarnow, MD, DMSc
Principal Investigator
Steno Diabetes Center Sjaelland, Denmark
Charlotte Bredahl Jacobsen, Senior Researcher, PhD.
Principal Investigator
Institute of Social Work, University College Copenhagen, Copenhagen, Denmark
Rikke Meyer, MD
Principal Investigator
Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported