Oxytocin and CBSST for People With Schizophrenia

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): CBSST + oxytocin (experimental) and CBSST + placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

A NIMH mission priority is the development of new and better interventions, whose focus extends beyond symptom amelioration to the development of interventions that allow people who suffer from severe mental illnesses "to live full and productive lives" (NIMH Strategic Plan, 2008).

In particular, this would be the first study to examine the safety of long-term oxytocin in this population.

The study will also provide critical data on the feasibility of recruiting and retaining participants with schizophrenia in a long-term intervention, which combines two different therapeutic modalities: CBSST and oxytocin.

Who Took Part

The registry lists 83 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder. Scale for the Assessment of Negative Symptoms asociality item score ≥ 2. Considered clinically stable by the treating psychiatrist. Male or female of any race.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, loss of consciousness (loc) for more than 30 minutes; mental retardation; participant is pregnant or is lactating.

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.

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 and investigator.

It started in 2014-01 with completion listed for 2016-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Birchwood Social Function Scale (BSFS) Total Score (time frame: Treatment weeks 0, 12, and 24, plus follow-up week 36).

It also tracked 5 secondary outcomes, for example Defeatist Performance Attitudes Scale (DPAS) Total Score, Asocial Belief Scale (ABS) Total Score, Schedule for Assessment of Negative Symptoms (SANS) Total Score, Brief Psychiatric Rating Scale (BPRS) Total Score and Brief Psychiatric Rating Scale (BPRS) Psychosis Score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 83 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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