Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study

What Was Tested

This registered phase 1 trial tested Oxytocin.

The purpose of this study is to determine whether an oxytocin ad-on, or oxytocin and tibolone ad-on can induce a response to antidepressants in patients with treatment resistant depression.

It had three arms (groups): Oxytocin (active comparator), Oxytocin and Tibolone (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Current DSM-IV diagnosis of Major Depression. Comorbid anxiety disorders secondary to depression will be included. A MADRS score \>20 at randomization. A negative pregnancy test at screening. A clinically acceptable Pap smear within the past 2 years.

The full record lists 10 inclusion and 15 exclusion criteria; among the exclusions: any previous history of adverse side-effects to escitalopram (or other ssri); use of oral contraceptives (or any hormonal method of contraception) for the duration of the study; DSM-IV defined substance dependence, history of bipolar disorder, schizoaffective disorder or schizophrenia.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2012-01 with completion listed for 2012-11.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Assessed at different time points: 1 week, 2 weeks, 4 weeks, 8 weeks).

It also tracked 7 secondary outcomes, for example Change from baseline in Hamilton Rating Scale for Depression (HAM-D), Change from baseline in Beck Depression Inventory II (BDI-II), Change from baseline in State Trait Anxiety Inventory (STAI), Adverse Symptom Check List, Perceived stress scale and Pittsburgh sleep quality index.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 15 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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