Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia

What Was Tested

The trial (phase 1) is built around Oxytocin.

Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one year.

Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray for 12 weeks.

It had two arms (groups): oxytocin (experimental) and Control spray (placebo comparator).

Twice daily treatment of oxytocin will be administered by subjects.

Self administration twice daily of intranasal spray that does not contain oxytocin.

The registry classes the interventions as drug.

More on the Plan

Except for Screening, all clinic visits will begin between 0800-1000 hours and subjects will have fasted since midnight.

Approximately 10 minutes after checking into the clinic, subjects' weight and vital signs will be measured followed by blood and urine sample collection.

Breakfast will then be served.

At regular intervals during each clinic visit, subjects will be allowed to rest for 15-20 minutes.

Who Took Part

68 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 18-65 yrs of age;. Currently meeting DSM-IV criteria for schizophrenia or schizoaffective disorder with onset occurring \> 1 year prior to enrollment in the study;. Get a minimum score of "3" on at least two of the following "social" items on the PANSS ratings: suspiciousness/persecution (ideation), hostility, passive/apathetic social withdrawal, uncooperativeness, active social avoidance,. Stable symptoms as well as being on the same medication and psychosocial therapy regimen for \> 1 month.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: history of mania or hypomania within the past two years; substance use or abuse disorder during the past 3 months (except tobacco, caffeine);; debilitating or inadequately controlled medical conditions (including dialysis, hiv infection without aids is not exclusionary);.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2011-07 with completion listed for 2015-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in social cognition scores from baseline to 6 and 12 week time points (time frame: Baseline, Week 6, and Week 12 visits).

It also tracked 2 secondary outcomes, for example Change in social functioning measures from baseline to 6 and 12 week time points and Change in PANSS total and subscale scores from baseline to 6 and 12 week time points.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 68 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.