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

What Was Tested

This registered not phased trial tested Oxytocin.

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.

The registry classes the interventions as other.

More on the Plan

Three core syndromes characterize SCZ: positive and negative syndromes (NS), as well as a cognitive syndrome.

The BNSS as a validated rater-based instrument designed for clinical trials will be collected by a blinded psychiatrist.

MBGT-sessions by experienced psychotherapists take place once a week over four weeks in a group of six patients.

They serve as a positive social context for OXT administration.

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2025-09-08 with completion listed for 2026-11-30.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in BNSS Brief Negative Symptom Scale (time frame: Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)).

It also tracked 14 secondary outcomes, for example Change and group differences in PANSS Positive and Negative Syndrome Scale, Change and group differences in SNS Self-Evaluation of Negative Symptoms, Change and group differences in CDSS Calgary Depression Scale of Schizophrenia, Change and group differences in PSS Perceived Stress Scale, Change and group differences in SMQ Southampton Mindfulness Questionnaire and Change and group differences in PANAS Positive and Negative Affect Scale.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 120 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.