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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
Syntocinon® nasal spray is applied according to description in arms section
Placebo nasal spray is applied according to description in arms section
Central Institute of Mental Health, Department of Psychiatry,
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGPersonal 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.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
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.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
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.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
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.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
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.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
WHO Disability Assessment Schedule (WHODAS 2.0) increase
Due to the expected enhanced social functioning in the OXT group we hypothesize a larger increase in WHODAS 2.0 in the exploratory arm.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Personal and Social Performance Scale (PSP)
Due to the expected enhanced social functioning in the OXT group we hypothesize a linear increase of total PSP score over the sequential study visits in both treatment arms, but more pronounced in the exploratory arm.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
B-CATS improvement
We hypothesize a larger improvement across the cognitive domains in the relevant psychometric tests (B-CATS) in the exploratory over the course of the study.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
Drop Out Rate
We hypothesize a smaller likelihood of discontinuation in the OXT group.
Time frame: from Visit 1 to Visit 4 i.e. 12 weeks
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