Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxytocin nasal spray, Placebo.
- Who it may be relevant to
- Registry conditions: Schizophrenia Spectrum Disorders (SSD). Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug Oxytocin nasal spray
Syntocinon® nasal spray is applied according to description in arms section - Other Placebo
Placebo nasal spray is applied according to description in arms section
Primary outcome measures
- Personal and Social Performance Scale (PSP) [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
Secondary outcome measures (8)
- Positive and Negative Symptom Scale (PANSS) reduction [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
- Clinical Global Impression-Schizophrenia scale (CGI-SCH) reduction [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
- Global Assessment of Functioning (GAF) increase [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
- Brief Psychiatric Rating Scale (BPRS) reduction [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
- WHO Disability Assessment Schedule (WHODAS 2.0) increase [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
- Personal and Social Performance Scale (PSP) [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
- B-CATS improvement [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
- Drop Out Rate [Time frame: from Visit 1 to Visit 4 i.e. 12 weeks]
Eligibility criteria
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.
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Central Institute of Mental Health, Department of Psychiatry, — Mannheim
Identifiers
NCT: NCT06881810 · OXY-APS · 2023-509433-40-00