OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia

What Was Tested

The trial (not phased) is built around 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.

It had two arms (groups): Oxytocin (active comparator) and Placebo (placebo comparator).

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 aim of this study in individuals with SSD is to examine the effect of combining OXT administration with MBGT on NS, affect, and stress.

The PANSS as a validated and structured clinical interview will be collected by a blinded psychiatrist.

MBGT - sessions by experienced psychotherapists take place over four weeks.

Who Took Part

The registry lists 42 actual participants took part.

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

Design: 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 2023-09-30 with completion listed for 2024-12-30.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in PANSS Negative Symptoms (time frame: Baseline (T0), post-intervention at week 4 (T4) and follow-up (week 8, T5)).

It also tracked 11 secondary outcomes, for example Change and group differences in BNSS Brief Negative Symptom Scale, Change and group differences in SNS Negative Symptoms, Change and group differences in CDSS Calgary Depression Scale of Schizophrenia, Change and group differences in cortisol saliva levels, Change and group differences in DASS-21 Depression, Anxiety, and Stress Scale and Change and group differences in stress via visual analogue scale (Bubbles).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 42 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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