Oxytocin Add-on for Stable Depressed Patients

What Was Tested

This registered not phased trial tested Oxytocin.

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

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.

Each subject will be enrolled for a 8 week treatment period after a screening phase.

Study procedure involves weekly clinic visits as an outpatient.

After 4 weeks, treatments will be crossed over such that subjects that received oxytocin will receive placebo and vice versa.

Who Took Part

1 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 Major Depressive Disorder or Dysthymia Disorder. MADRS score of \>17 at randomization. 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; any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.

How the Study Was Run

Design: randomized, crossover and triple-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.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2010-10 with completion listed for 2015-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total Score on Montgomery-Asberg Depression Rating Score (MADRS) (time frame: Performed at each visit (weekly)).

It also tracked 12 secondary outcomes, for example Global Assessment of Functioning (GAF), Clinical Global Impression-Severity of Illness (CGI-S), Young Mania Rating Scale (YMRS), Hamilton-Anxiety Scale (HAM-A), Reading Trust in the Mind's Eye Test and Profile of Mood States (POMS).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 1 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.