Trial · Interventional

CompletedNot applicableRegistry data

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

Short name GnRHa

NCTNCT02661789Other idGnRHaOther idH-2-2010-108

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 63 participants (actual)
Sponsor: Gitte Moos Knudsen · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Denmark
Start: Jan 2011
Primary completion: Dec 2012
Completion: Dec 2012
First posted: 22 Jan 2016 (estimated)
Last update posted: 22 Jan 2016 (estimated)
Conditions: Postpartum Depression · Major Depressive Disorder · Postpartum Psychosis · Menopause · Neurodegeneration · Schizophrenia

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

N/A
GnRHa
NCT02661789
Jan 2011 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The project aimed at identifying neuropsychobiological signatures of pharmacological sex-steroid hormone manipulations in healthy women as a risk model for depression. 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. Participants were randomized to active Gonadotrophin-Releasing-Hormone agonist (GnRHa) (goserelin 3.6 mg implant) or placebo (saline injection) intervention, which was initiated in the mid follicular phase (i.e. cycle day 22.6 ±2.5). Sixty women completed follow-up and entered the analyses, except for a few drop outs on some domains. The following domains were addressed at baseline and at follow-up (16±3 days post intervention), (which corresponded to the early ovarian suppression phase of the biphasic hormone response to GnRHa): 1) serotonin transporter binding as imaged by 11CDASB Positron Emission Tomography (PET), 2) functional Magnetic Resonance Imaging (fMRI) emotional processing, 3) fMRI reward processing, 3) rating state fMRI (rsfMRI), 4) structural MRI, 5) Neuropsychology, 6) Psychophysiology, 7) Hypothalamus-Pituitary-Adrenal cortex (HPA)-axis dynamics, 8) Peripheral markers of immunoactive cell responses, 9) Epigenetic factors. Psychometrics in terms of self reported mental distress and interview based ratings were monitored across the intervention period to monitor potential symptoms of mental distress and psychopathology. Also ovarian hormone responses, peripheral blood markers, and side effects scores were collected across the intervention period.

Interventions

Goserelin 3.6 mg implantDrug
PlaceboDrug

Arms2

Active comparator
GnRHa
Goserelin 3.6 mg implant
Placebo comparator
Placebo
Injection of saline

Primary outcomes15

Outcomes the sponsor listed as primary.

Changes from baseline in symptoms of depression
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Hamilton 17 item score
Changes from baseline in serotonin transporter binding in volumes of interest (VOIs)
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
PET scan assessed serotonin transporter binding changes
Changes from baseline in fMRI response to emotional faces
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
fMRI response changes to emotional faces in emotion processing network including amygdala reactivity
Changes from baseline in fMRI response to gambling paradigm
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
fMRI response changes to reward (monetary win) paradigm in reward processing network
Changes from baseline in rsfMRI changes in functional connectivity
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
rsfMRI changes in functional connectivity in response to intervention
Changes from baseline in affective cognition (VAMT-24 test)
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Neuropsychological (VAMT-24 test) outcomes on affective cognition
Changes from baseline in reaction time
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Changes in reaction time
Serial mood fluctuations (SD of total mood disturbance (TMD) score of daily POMS across intervention period)
Time frame · Intervention start to follow-up 16±3 days after intervention
Registry description
Mood fluctuations measured by serial collection of daily POMS
Changes from baseline in hippocampal volume
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Hippocampal volumes from structural MRI
Changes in pre-pulse-inhibition (PPI) from baseline
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Change in amplitude of the startle response to pulse after pre-pulse warning as measured by EMG in the orbicularis oculi muscle (subtraction of averages across a series of 10 repititions at baseline and at follow-up 16±3 days).
Changes in a set of markers of immunoactivity across study period
Time frame · Baseline, intervention time, flare-up phase and follow-up
Registry description
Cytokines, hsCRP and gene transcript profile markers of
Changes in epigenetic markers of estrogen sensitivity
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Epigenetic (methylation) markers
Changes in HPA-axis dynamics (the cortisol awakening response)
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
The cortical awakening response
Changes in sensorimotor gating (P50 suppression) from baseline
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Changes in sensorimotor gating (P50 suppression) from baseline
Changes from baseline in hippocampal microstructure
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Hippocampal microstructure from MRI

Secondary outcomes(7)

Changes from baseline in fMRI responses to emotional memory paradigm
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Changes in brain activation to fMRI emotional memory paradigm - delayed recall forgetting of word prior to emotional disturbance
Changes from baseline in Cohens perceived stress score
Time frame · Baseline to follow-up 16±3 days after intervention
Registry description
Changes Cohens perceived stress score
Changes in Pittsburg Sleep Quality Inventory (PSQI)
Time frame · Baseline and 1 time per week until follow-up at 16 ±3 days
Registry description
Sleep quality self reported weekly across intervention period
Side effects scores (project specific 15 items questionnaire)
Time frame · 7, 12 and 30 days post intervention
Registry description
Total side effect score across and after intervention period
Changes in SCL-R (Symptom check-list revised)
Time frame · Baseline and 1 time per week from intervention to follow up at 16±3 days post intervention
Registry description
Changes in symptoms of psychopathology across intervention period
Major Depression Inventory (MDI)
Time frame · Baseline and 1 time per week from intervention to follow up at 16±3 days post intervention
Registry description
Changes in self-reported symptoms of depression across intervention period
Changes in profile of mood states (POMS TMD score)
Time frame · Baseline and 1 time per week from intervention to follow up at 16±3 days post intervention
Registry description
Changes in self-reported symptoms of mental distress across intervention period

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

4 results

Pharmacologically Induced Sex Hormone Fluctuation Effects on Resting-State Functional Connectivity in a Risk Model for Depression: A Randomized Trial.

Fisher et al. 2017Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 35

PMID 27649641PMC5399242DOI 10.1038/npp.2016.208PUB-27649641

Rights unknown4 results

Source link See results (4)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedMehta D, Rex-Haffner M, Sondergaard HB, Pinborg A, Binder EB, Frokjaer VG. Genome-wide gene expression in a pharmacological hormonal transition model and its relation to depressive symptoms. Acta Psychiatr Scand. 2019 Jul;140(1):77-84. doi: 10.1111/acps.13038. Epub 2019 May 24. PMID 31099405

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Healthy women * Regular menstrual cycles (23 -35 days cycle length) * No systemic or intrauterine steroid hormone use Exclusion Criteria: * 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 * Conditions that may increase risk by participating in the study program including ovarian cysts * Pregnancy during the last year * Delivery during the last 2 years * Presently wishing to obtain pregnancy * Breast feeding * Not fluent in Danish or severe visual or hearing impairments * Earlier or present learning disabilities * Claustrophobia (due to MRI scans) * Metal implants (excludes MRI)

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