RecruitingNot ApplicableNCT07265180

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)


Sponsor

Charite University, Berlin, Germany

Enrollment

120 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether oxytocin — sometimes called the "bonding hormone" — given as a nasal spray before group therapy sessions can improve social connection and reduce symptoms in people with schizophrenia. The study compares two different doses of oxytocin. **You may be eligible if...** - You have a diagnosis of schizophrenia or a related condition (on the F2 spectrum) - Your positive symptoms (such as hallucinations or unusual beliefs) are mild to moderate, not severe - You speak German as your native language or at a native level - Your psychiatric medications have been stable for the past 2 weeks **You may NOT be eligible if...** - You are currently experiencing a severe psychotic episode - You are actively suicidal - You are currently in an active phase of substance dependence (other than nicotine) - You have a serious physical or neurological illness - You are pregnant or breastfeeding - You are currently receiving electroconvulsive therapy (ECT) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROxytocin

Oxytocin nasal spray in combination with mindfulness based group therapy (MBGT).

OTHERPlacebo

Placebo nasal spray in combination with mindfulness based group therapy (MBGT).


Locations(1)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Campus Charité Mitte

Berlin, State of Berlin, Germany

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NCT07265180


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