Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

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

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 98 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Age 18 to 64 years. Written informed consent (must be available before enrolment in the clinical trial). ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline). In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients); coercive treatment at the time of study inclusion; documented intolerance to the study drug or any of its ingredients.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2024-08-29 with completion listed for 2028-03-31.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Personal and Social Performance Scale (PSP) (time frame: from Visit 1 to Visit 4 i.e. 12 weeks).

It also tracked 8 secondary outcomes, for example Personal and Social Performance Scale (PSP) and Drop Out Rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 98 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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