CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 153 enrolled
Drug / intervention
Amisulpride +1 moredrug
Likely dose
Amisulpride 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01701258
NCT01701258Phase 1Completed

Early Life Stress and Depression: Molecular and Functional Imaging Approaches

Mclean Hospital·interventional·Posted Oct 5, 2012·Updated May 7, 2025

In Brief

A Phase 1 clinical trial evaluating Amisulpride and Placebo for Major Depressive Disorder (MDD) and History of Childhood Sexual Abuse (CSA). Completed, enrolled 153 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2012
Enrollment StartAug 1, 2013
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.7 years ago

Interventions

Amisulpridedrug

single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only

Placebodrug

single-dose placebo capsule during the fMRI session only