Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment

Launched by CENTRAL INSTITUTE OF MENTAL HEALTH, MANNHEIM · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial, called OXY-APS, is studying how a hormone called oxytocin can help improve social skills in people with schizophrenia spectrum disorders (SSD). Researchers believe that oxytocin, which plays a role in our social interactions and emotions, might help patients better connect with others when used alongside regular psychosocial treatments, such as therapy or support groups. The goal is to enhance the quality of life for individuals with SSD by addressing challenges they face in social situations.

To participate in this study, individuals need to be between the ages of 18 and 64 and have a confirmed diagnosis of schizophrenia or a related disorder. They should also experience some social difficulties and be receiving regular psychosocial treatment at least twice a week. Participants will be randomly assigned to receive either oxytocin or a placebo (a non-active treatment) for a certain period, all while continuing their usual treatment. Before joining, everyone will need to provide written consent and meet some basic health criteria, ensuring their safety during the trial. This research is important as it may lead to better support and understanding of SSD, ultimately helping to reduce stigma and improve treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 64 years
• • 2. Written informed consent (must be available before enrolment in the clinical trial)
• • 3. ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview
• • 4. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline).
• • 5. In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study
• • 6. Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.
• • 1. Age 18 to 64 years 2. Written informed consent (must be available before enrolment in the clinical trial) 3. ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview 4. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline). 5. In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study 6. Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.
• Exclusion Criteria:
• • 1. Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)
• • 2. Coercive treatment at the time of study inclusion
• • 3. Diagnosis of primary substance dependency other than nicotine: exclusion alcohol dependency via AUDIT-screening (Bohn, Babor et al. 1995; Babor et al. 2001) and ICD- 11 criteria (MINI-DIPS-OA); exclusion of other drug dependencies other than alcohol and nicotine: drug screening of urine and ICD-11 criteria (MINI-interview: patient fulfilling early (\> 3 months) or sustained (\>12 months) remission criteria and/or with low severity of substance use disorder according to MINI (ICD-11) are eligible for the study).
• • 4. Documented intolerance to the study drug or any of its ingredients.
• • 5. Pregnancy (incl. positive urine or blood pregnancy test) / breastfeeding (female patients) or lactating individuals
• • 6. Severe endocrinological disorder besides diabetes
• • 7. Endometriosis
• • 8. Concurrent participation