Oxytocin Add on Study for Stable Schizophrenic Patients

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had two arms (groups): Group 1 (experimental) and Group 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

Oxytocin is a neurohypophyseal peptide best known for its role as a neurohormone involved in parturition and lactation.

Oxytocin and its receptors exist in several areas of the brain which have been heavily implicated in the pathophysiology of schizophrenia, such as the nucleus accumbens and the hippocampus, (Van Leeuwan et al 1985).

Oxytocin administered peripherally inhibits dopamine transmission in the mesolimbic pathway (Sarnyai 1992) et al, 1990).

Each subject will be enrolled for 6 week treatment period after a screening phase Study procedure involves weekly clinic visits as an outpatient.

Who Took Part

Enrollment: 21 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Adult men or women, 18 years of age or older. Meet DSM-IV criteria for Schizophrenia. A minimum PANSS total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline. Must be able to use nasal spray.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: are pregnant or are breastfeeding (negative pregnancy test at screening); A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse; are unsuitable in any way to participate in this study, in the opinion of the investigator.

How the Study Was Run

Design: randomized, crossover and triple-blind.

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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

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

It started in 2008-03 with completion listed for 2014-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Total Score in the Positive and Negative Syndrome Scale (PANSS) (time frame: performed at each visit (weekly)).

It also tracked 12 secondary outcomes, for example Clinical Global Impression-Severity of Illness, Calgary Depression Scale for Schizophrenia, Global Assessment of Functioning, Hamilton Anxiety Scale, Peabody Picture Vocabulary Test and Letter Number Sequencing Memory Test.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 21 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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