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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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
• Treatments: Goserelin; Hormones

Criteria

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)