Comparing intranasal oxytocin doses added to group psychotherapy for schizophrenia.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.