Neuropsychobiological Correlates of Sex-steroid Hormone Manipulation in Healthy Women: a Risk Model for Depression
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Gitte Moos Knudsen
Collaborators:
Center for Integrated Molecular Brain Imaging Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak CNSR, Glostrup Psychiatric Center Danish Multiple Sclerosis Center Rigshospitalet Dept. of Clinical Immunology, Rigshospitalet Fertility Clinic Rigshospitalet