Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia

What Was Tested

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

The project is designed to address the following two primary aims: 1.

It had three arms (groups): 1: galantamine/placebo-oxytocin (active comparator), 2: oxytocin/placebo-galantamine (active comparator) and 3: placebo-galantamine /placebo-oxytocin (placebo comparator).

Subjects randomized to galantamine will receive galantamine and placebo-oxytocin.

Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine.

Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 86 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: Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder. Judged clinically stable and will not exceed threshold levels of positive, depressive, and/or extrapyramidal symptoms. The minimum level of negative symptoms will be defined as follows:. Scale for the Assessment of Negative Symptoms (SANS) total score (minus the global items, and inappropriate affect, poverty of content of speech and attentional items) 20 or greater; OR. SANS alogia global item score 3 or greater.

The full record lists 11 inclusion and 6 exclusion criteria; among the exclusions: female participants may not be pregnant.

How the Study Was Run

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

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

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

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

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

It started in 2010-02 with completion listed for 2014-07.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Scale for the Assessment of Negative Symptoms (SANS) Total Score (time frame: Every other week for 6 weeks). Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week (time frame: Treatment Week 0 and Week 6).

It also tracked 81 secondary outcomes, for example Scale for the Assessment of Negative Symptoms (SANS) - Avolition, Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia, Scale for the Assessment of Negative Symptoms (SANS) - Alogia, Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect, 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 phase 2, randomized trial of Oxytocin in 86 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.