RecruitingPhase 2NCT06881810

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)


Sponsor

Central Institute of Mental Health, Mannheim

Enrollment

98 participants

Start Date

Aug 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding oxytocin — a naturally occurring hormone sometimes called the "social bonding" hormone — as a nasal spray improves social skills training for people with schizophrenia or related psychotic disorders. Many people with schizophrenia have difficulty with social interactions, and this trial investigates whether oxytocin can enhance the benefits of standard psychosocial treatment. **You may be eligible if:** - You are between 18 and 64 years old - You have a confirmed diagnosis of schizophrenia or another primary psychotic disorder - You have at least one moderate or severe negative symptom (such as reduced motivation, flat emotions, or social withdrawal) - You are receiving regular psychosocial (social or psychological) treatment at least twice a week **You may NOT be eligible if:** - You are outside the 18–64 age range - You do not have a diagnosis of schizophrenia or a related psychotic disorder - You have conditions that make oxytocin unsafe (e.g., certain hormonal conditions) - You are pregnant or breastfeeding - You are not currently in regular psychosocial treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxytocin nasal spray

Syntocinon® nasal spray is applied according to description in arms section

OTHERPlacebo

Placebo nasal spray is applied according to description in arms section


Locations(1)

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, Germany

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NCT06881810


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