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.
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).
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.
Parallel
Oxytocin nasal spray
DrugSyntocinon® nasal spray is applied according to description in arms section
Placebo
Other interventionPlacebo nasal spray is applied according to description in arms section
Personal and Social Performance Scale (PSP)
The main purpose of this clinical trial is to evaluate the efficacy and safety of OXT combined with psychosocial interventions for improving social skills and psychopathology in SSD. We hypothesize a greater absolute PSP score improvement when OXT is administered together with the psychosocial intervention.
Positive and Negative Symptom Scale (PANSS) reduction
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger PANSS total score reduction comparing V1 and V4 in the exploratory arm and a linear decrease of total PANSS score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger CGI-SCH reduction comparing V1 and V4 in the exploratory arm and a linear decrease of total CGI-SCH score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Global Assessment of Functioning (GAF) increase
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger GAF increase comparing V1 and V4 in the exploratory arm and a linear increase of GAF total score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Brief Psychiatric Rating Scale (BPRS) reduction
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger BPRS reduction in the exploratory arm and a linear decrease of total BPRS score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Click on the lead sponsor to view all of their trials.
