Using oxytocin to improve social skills in people with schizophrenia
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)
This study is testing if an oxytocin nasal spray can help people with schizophrenia improve their social skills while they continue their regular therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Central Institute of Mental Health, Mannheim Academic / other |
| Locations | 1 site (Mannheim, Baden-Wurttemberg) |
| Trial ID | NCT06881810 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oxytocin nasal spray as an add-on treatment to psychosocial interventions for patients with schizophrenia spectrum disorders (SSD) who experience social impairments. The study aims to enhance social skills and reduce stigma associated with SSD by addressing social cognition deficits through the administration of oxytocin. Participants will receive either the oxytocin treatment or a placebo while continuing their regular psychosocial therapy. The trial seeks to determine if oxytocin can significantly improve social functioning in these individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 64 with a diagnosis of schizophrenia or other primary psychotic disorders who are currently receiving psychosocial treatment.
Not a fit: Patients who do not have a diagnosis of schizophrenia spectrum disorders or those not engaged in regular psychosocial treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved social skills and quality of life for patients with schizophrenia spectrum disorders.
How similar studies have performed: While the use of oxytocin in this context is relatively novel, previous studies have suggested potential benefits of oxytocin in enhancing social cognition in various populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mannheim, Baden-Wurttemberg
- Central Institute of Mental Health, Department of Psychiatry, — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Dusan Hirjak, Prof. Dr. — Central Institute of Mental Health
- Study coordinator: Dusan Hirjak, Prof. Dr.
- Email: dusan.hirjak@zi-mannheim.de
- Phone: 0621 1703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.