Oxytocin Add-on Study for Stable Anxiety Patients

What Was Tested

The trial (not phased) is built around Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

For example, plasma oxytocin levels may function as an index of central serotonin (5-HT) function in human subjects, and serotonin is well-known to be involved in clinical anxiety disorders.

Since oxytocin is released directly from limbic-hypothalamic cells, this response presumably represents a direct central assessment of 5-HT response in limbic-hypothalamus (Lee 2003).

The results from this study provide specific behavioral and autonomic evidence of anxiolytic-like effects for oxytocin.

In primates, Emiliano et al 2007 found support for the idea that that SSRIs' therapeutic effects on social affiliation and anxiety may be mediated in part through components of the oxytocin system.

Who Took Part

Enrollment: 17 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: HAM-A total score ≥15 with Item 1 (anxious mood) and Item 2 (tension) scores ≥2 at randomization. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline;. Adult men or women, 18 years of age or older. Must be able to use nasal spray.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: are pregnant or are breastfeeding; A urine drug screen at screening that is positive for recent use of illegal drugs or alcohol; any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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 2009-02 with completion listed for 2011-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Total Score on the Hamilton Anxiety Scale (HAM-A) (time frame: Performed at each visit (weekly)).

It also tracked 11 secondary outcomes, for example Clinical Global Impression - Severity of Illness (CGI-S, Social Phobia Inventory (SPIN), The State-Trait Anxiety Inventory (STAI), The Profile of Mood States (POMS), Sheehan Disability Scale (SDS) and Arizona Sexual Experience Scale (ASEX).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 17 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.