NCT07265180Recruiting
Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison
Oxytocin-Augmented Mindfulness-Based Group Psychotherapy for Patients With Schizophrenia Spectrum Disorders - an Oxytocin-dose Comparison (OXYMIND2.0)
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated lower NS by OXT administration in a positive social context of mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS with a higher OXT dosage. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 8 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Schizophrenia
- NCT number
- NCT07265180
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 8 Sept 2025 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Other illness
- No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage
- Disease of the endocrine system
- Metabolic diseases
Lab values
- Change in blood potassium or sodium levels
Other
- 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
- Pregnancy and breastfeeding
- Overweight or underweight (body mass index (BMI) \< 17.5 or \> 30)
- Impaired kidney or liver function
- Asthma
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Campus Charité Mitte Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.