NCT01701258

An Investigation of Early Life Stress and Depression

Early Life Stress and Depression: Molecular and Functional Imaging Approaches

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate brain pathways within adult females (with a history of CSA that occurred between the ages of 5-14) with and without a current diagnosis of major depressive disorder (MDD). Hypotheses: The CSA/MDD participants will be characterized by (1) reduced reward responsiveness and prefrontal cortex activity, but increased cortisol levels, (2) reduced dopamine activity, and (3) reduced dopamine transporter binding. The over-arching purpose of the study is to (1) identify individuals at risk for psychopathology and maladaptive behavior, (2) prevent re-victimization, and (3) develop more targeted therapeutic interventions.

Detailed description

This study will include four sessions: Session 1 (SCID Session) The first session takes place at the Center for Depression, Anxiety, and Stress Research (CDASR) or Neuroimaging Center (both at McLean Hospital) and involves consenting, a clinical evaluation, a series of questionnaires, and a medical assessment. Session 2 or 3 (fMRI Session) The third session takes place at the Neuroimaging Center. Using a double-blind design, participants will be administered either amisulpride (50 mg) or placebo. Participants will complete the Monetary Incentive Delay (MID) task during functional magnetic resonance imaging (fMRI) and the Probabilistic Stimulus Selection Task (PSST) afterwards. Session 2 or 3 (PET Session) This session takes place at Massachusetts General Hospital. 9 mCi of \[11C\] altropane will be injected by a trained nuclear medicine technician and positron emission tomography (PET) scanning will begin. Prior to the PET scan, a blood serum pregnancy test will be administered for females. Session 4 (ERP Session) The fourth session takes place at the CDASR and involves an electroencephalography (EEG) recording, the Probabilistic Reward Task (PRT), and collecting saliva samples to assess cortisol levels.

Conditions

• Major Depressive Disorder (MDD)
• History of Childhood Sexual Abuse (CSA)

Interventions

Type	Name	Description
DRUG	Amisulpride	single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
DRUG	Placebo	single-dose placebo capsule during the fMRI session only

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2012-10-05
• Last updated: 2025-05-07
• Results posted: 2018-05-18

Locations

2 sites across 1 country: United States