NCT06881810

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

Enhancing Social Skills in Schizophrenia Spectrum Disorders - Two-arm, Double-blind, Randomized Clinical Trial Investigating Oxytocin vs. Placebo as an add-on to an Individualized Psychosocial Treatment (OXY-APS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Central Institute of Mental Health, Mannheim · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Research on schizophrenia spectrum disorders (SSD) patients with social impairment is essential for improving treatment, enhancing the lives of affected individuals, reducing stigma, and advancing our understanding of this complex psychiatric disorder. A clinical trial focusing on the improvement of social skills in SSD has the potential to transform clinical practice and support systems to better meet the needs of those living with SSD. Because of the role of oxytocin in regulating social behaviors and emotions, the investigator hypothesizes that it is beneficial in addressing the social cognition deficits observed in SSD when combined with psychosocial interventions.

Conditions

• Schizophrenia Spectrum Disorders (SSD)

Interventions

Type	Name	Description
DRUG	Oxytocin nasal spray	Syntocinon® nasal spray is applied according to description in arms section
OTHER	Placebo	Placebo nasal spray is applied according to description in arms section

Timeline

• Start date: 2024-08-29
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-03-18
• Last updated: 2025-03-21

Locations

1 site across 1 country: Germany