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

Inclusion criteria

• Age 18 to 64 years
• Written informed consent (must be available before enrolment in the clinical trial)
• ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview
• 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).
• In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study
• 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.

• 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

• Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)
• Coercive treatment at the time of study inclusion
• 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).
• Documented intolerance to the study drug or any of its ingredients.
• Pregnancy (incl. positive urine or blood pregnancy test) / breastfeeding (female patients) or lactating individuals
• Severe endocrinological disorder besides diabetes
• Endometriosis
• Concurrent participation