NCT06136390Completed
OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
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 a lower NS by OXT administration in the positive social context of MBGT in SSD. The investigators also demonstrated that NS and other symptoms improved after mindfulness-based group psychotherapy (MBGT). The aim of this study in individuals with SSD is to examine the effect of combining OXT administration with MBGT on NS, affect, and stress with psychological and biological markers. 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. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 4 Nov 2023
- Start date
- 30 Sept 2023
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Schizophrenia
- NCT number
- NCT06136390
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 30 Sept 2023 to the primary completion date, 30 Dec 2024
- 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 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 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.