Oxytocin-enhanced group therapy for schizophrenia patients
OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
This study is testing if giving oxytocin along with group therapy can help improve social skills and reduce negative feelings in people with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06136390 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of combining oxytocin administration with mindfulness-based group therapy (MBGT) on negative symptoms and social cognition in patients with schizophrenia spectrum disorders. The research aims to enhance functional connectivity between brain networks involved in social reward and socioemotional processes, which are often impaired in these patients. Participants will receive either oxytocin or a placebo while engaging in group therapy sessions. The study will assess changes in negative symptoms, affect, and stress levels over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with schizophrenia who exhibit mild to moderate positive symptoms and can communicate in German.
Not a fit: Patients experiencing acute psychotic episodes, severe positive symptoms, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve social functioning and reduce negative symptoms in patients with schizophrenia.
How similar studies have performed: While some studies have explored oxytocin's effects on social cognition, this specific combination of oxytocin with MBGT is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * declaration of consent * Psychiatric diagnosis of schizophrenia (ICD-10: F2x.x spectrum) for group of patients * Mild to moderate positive symptoms (5 ≤ Positive symptoms on individual items using P- PANSS) * German should either be the native language or spoken at a native level. * No change in systematically recorded psychopharmacological medication in the last 2 weeks before study inclusion. Exclusion Criteria: * Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 6 ≥ positive symptoms on individual items using P-PANSS). * Acute suicidality * Acute consumption phase of a substance dependence, except nicotine * No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage * Pregnancy and breastfeeding * Current electroconvulsive therapy If one of the following criteria applies to the participants, we will conduct an individual consultation in advance to determine whether participation in the study is possible: * Overweight or underweight (body mass index (BMI) \< 17.5 or \> 30) * Disease of the endocrine system * Impaired kidney or liver function * Metabolic diseases * Asthma * Change in blood potassium or sodium levels
Where this trial is running
Berlin
- Charité Universitätsmedizin Berlin, Campus Benjamin Franklin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Marco Zierhut, MD — Charite University, Berlin, Germany
- Study coordinator: Marco Zierhut, MD
- Email: marco.zierhut@charite.de
- Phone: 004930450517547
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.