Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509433-40-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | A single dose of 80 I.U. oxytocin in aerosol form (Syntocinon® nasal spray) is administered via 20 puffs 2 times per week intranasally. 1 ml of Syntocinon nasal spray contains 40 I.U. of oxytocin, with one puff equivalent to 0.1 ml of nasal spray (4 I.U. per spray). To reach the dose of 80 I.U. a total of ten spray puffs per nostril are required (1 ml per Nostril, 2 ml in total). The nasal spray is applied in a sitting position:
|
|
| Placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin nasal spray | Drug | Syntocinon® nasal spray is applied according to description in arms section |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from Visit 1 to Visit 4 i.e. 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from Visit 1 to Visit 4 i.e. 12 weeks |
Not provided
Inclusion Criteria:
1. 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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dusan Hirjak, Prof. Dr. | Contact | 0621 1703 | 2540 | dusan.hirjak@zi-mannheim.de |
| Name | Affiliation | Role |
|---|---|---|
| Dusan Hirjak, Prof. Dr. | Central Institute of Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Institute of Mental Health, Department of Psychiatry, | Recruiting | Mannheim | Baden-Wurttemberg | 68159 | Germany |
Not provided
two-arm, double-blind, randomized
Not provided
Not provided
Not provided
| Placebo | Other | Placebo nasal spray is applied according to description in arms section |
|
| 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. | 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. | 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. | 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. | 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. | 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. | from Visit 1 to Visit 4 i.e. 12 weeks |
| Drop Out Rate | We hypothesize a smaller likelihood of discontinuation in the OXT group. | from Visit 1 to Visit 4 i.e. 12 weeks |