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An Investigation of Early Life Stress and Depression

NCT01701258 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-05-07

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Diego Pizzagalli, PhD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701258 on ClinicalTrials.gov