Actively Recruiting
Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment
Led by Central Institute of Mental Health, Mannheim · Updated on 2025-03-21
98
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 64 years
- Written informed consent before enrolment
- ICD-11 diagnosis of schizophrenia or other primary psychotic disorders confirmed by MINI-DIPS-OA Interview
- At least one moderate or worse symptom on the PANSS negative subscale (score 64 for symptoms N1-N7 at baseline)
- Receiving in- or outpatient psychosocial treatment at least twice a week during the study
- Male participants and female participants who are not able to bear children or female patients of childbearing potential using a medically approved highly effective birth control method at screening
You will not qualify if you...
- Patients deemed unsuitable by the investigator, including acutely suicidal patients
- Under coercive treatment at study inclusion
- Primary substance dependency other than nicotine or alcohol dependency (based on AUDIT-screening and MINI-DIPS-OA criteria)
- Documented intolerance to the study drug or its ingredients
- Pregnancy, breastfeeding, or lactating female patients
- Severe endocrinological disorders besides diabetes
- Endometriosis
- Concurrent participation in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Central Institute of Mental Health, Department of Psychiatry,
Mannheim, Baden-Wurttemberg, Germany, 68159
Actively Recruiting
Research Team
D
Dusan Hirjak, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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