Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Schizophrenia Spectrum Disorders (SSD)

In brief

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.

Key facts

Study ID: NCT07265180
Run by: Charite University, Berlin, Germany
People needed: 120
Starts: 2025-09-08
Expected to finish: 2026-11-30
Last updated by the study team: 2025-12-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Campus Charité Mitte — Berlin, State of Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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