Clinical trial NCT06881810: Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment
Official title: Enhancing Social Skills in Schizophrenia Spectrum Disorders - Two-arm, Double-blind, Randomized Clinical Trial Investigating Oxytocin vs. Placebo as an add-on to an Individualized Psychosocial Treatment (OXY-APS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Schizophrenia Spectrum Disorders (SSD)
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm, double-blind, randomized
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

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:

1. Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)
2. Coercive treatment at the time of study inclusion
3. 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).
4. Documented intolerance to the study drug or any of its ingredients.
5. Pregnancy (incl. positive urine or blood pregnancy test) / breastfeeding (female patients) or lactating individuals
6. Severe endocrinological disorder besides diabetes
7. Endometriosis
8. Concurrent participation

Primary outcomes:
measure: Personal and Social Performance Scale (PSP)
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
Secondary outcomes:
measure: Positive and Negative Symptom Scale (PANSS) reduction
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
measure: Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
measure: Global Assessment of Functioning (GAF) increase
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
measure: Brief Psychiatric Rating Scale (BPRS) reduction
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
measure: WHO Disability Assessment Schedule (WHODAS 2.0) increase
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
measure: Personal and Social Performance Scale (PSP)
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
measure: B-CATS improvement
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
measure: Drop Out Rate
timeFrame: from Visit 1 to Visit 4 i.e. 12 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health, Department of Psychiatry,
state: BW
Study officials:
affiliation: Central Institute of Mental Health
name: Dusan Hirjak, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: