Comparing intranasal oxytocin doses added to group psychotherapy for schizophrenia.
Oxytocin-Augmented Mindfulness-Based Group Psychotherapy for Patients With Schizophrenia Spectrum Disorders - an Oxytocin-dose Comparison (OXYMIND2.0)
This study will try different doses of intranasal oxytocin given with mindfulness-based group psychotherapy to see if they reduce negative symptoms and improve social cognition 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, State of Berlin) |
| Trial ID | NCT07265180 on ClinicalTrials.gov |
What this trial studies
Oxytocin may enhance brain network connectivity involved in social reward and socioemotional processing, which could reduce negative symptoms and sociocognitive deficits in schizophrenia. In this interventional study, adults with schizophrenia receiving stable medication attend mindfulness-based group psychotherapy and are given intranasal oxytocin at different doses or placebo alongside the therapy. Outcomes include negative symptoms and standardized measures of social cognition, and the study will explore whether effects depend on dose, social context, plasma oxytocin levels, and OXTR genetic variants. Participants must speak German, have mild-to-moderate positive symptoms, and be able to attend on-site sessions at Charité clinics in Berlin, while those with acute psychosis, active substance dependence (except nicotine), pregnancy, breastfeeding, or recent ECT are excluded.
Who should consider this trial
Good fit: Adults with a schizophrenia-spectrum diagnosis who speak German, have mild-to-moderate positive symptoms, and stable psychopharmacological medication are the intended participants.
Not a fit: People with acute severe psychosis, acute suicidality, current acute substance dependence (except nicotine), pregnancy or breastfeeding, severe neurological conditions, or undergoing acute ECT are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adding the right dose of intranasal oxytocin to group psychotherapy could meaningfully reduce negative symptoms and improve social functioning.
How similar studies have performed: Prior studies show oxytocin improves social cognition in healthy people but results in schizophrenia have been inconsistent, though small pilots suggest benefit when oxytocin is paired with positive social interventions like group psychotherapy.
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 acute 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, State of Berlin
- Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Campus Charité Mitte — Berlin, State of 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.