Neuropsychobiological Correlates of Sex-steroid Hormone Manipulation in Healthy Women: a Risk Model for Depression

What Was Tested

This registered not phased trial tested Goserelin.

The study is a double-blind, randomized, placebo-controlled study.

Investigators included 63 healthy female volunteers with regular menstrual cycles between 23 and 35 days.

It had two arms (groups): GnRHa (active comparator) and Placebo (placebo comparator).

Injection of saline.

The registry classes the interventions as drug.

More on the Plan

E.g. the vulnerability to mood and anxiety disorders is considerably greater in women.

Among other factors, this possibly reflects gender differences in central serotonergic function since dysfunction of serotonergic neurotransmission is critically involved in the pathophysiology of mood and anxiety disorders, schizophrenia, and Alzheimer's disease.

In particular, women going through phases in life where sex hormones decline rapidly from high levels or fluctuate, have a higher frequency of severe mood state changes and are more vulnerable to psychiatric disorders, e.g. across the pre to postpartum and menopausal transition.

In this project investigators aimed at investigating whether sex-hormone manipulation affects: 1.

Who Took Part

63 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Regular menstrual cycles (23 -35 days cycle length). No systemic or intrauterine steroid hormone use.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: psychiatric disorder (dsm iv axis i or who icd-10 diagnostic classification); prior or present neurological or other severe medical condition including substance abuse; no drug intake suspected to influence results.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

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 Goserelin.

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

It started in 2011-01 with completion listed for 2012-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Changes from baseline in symptoms of depression (time frame: Baseline to follow-up 16±3 days after intervention). Changes from baseline in serotonin transporter binding in volumes of interest (VOIs) (time frame: Baseline to follow-up 16±3 days after intervention). Changes from baseline in fMRI response to emotional faces (time frame: Baseline to follow-up 16±3 days after intervention).

It also tracked 7 secondary outcomes, for example Changes from baseline in fMRI responses to emotional memory paradigm, Changes from baseline in Cohens perceived stress score, Changes in Pittsburg Sleep Quality Inventory (PSQI), Side effects scores (project specific 15 items questionnaire), Changes in SCL-R (Symptom check-list revised) and Major Depression Inventory (MDI).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Goserelin in 63 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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