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NCT01701258 · ClinicalTrials.gov registry record · Phase 1

An Investigation of Early Life Stress and Depression

A Phase 1 study, sponsored by Mclean Hospital.

Completed
Registry status
Phase 1
Development phase
153
Enrollment target

NCT01701258 is a Phase 1 study that has completed, run by Mclean Hospital. The registered enrollment target is 153 participants.

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The verdict

NCT01701258, a Phase 1 study, has completed, sponsored by Mclean Hospital.

COMPLETED
Registry status
Phase 1
Development phase
153 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Amisulpride

Trial Details

FieldValue
Enrollment Target 153 participants
Start Date 2013-08
Est. Completion 2017-05
Phase Phase 1

Sponsor

Mclean Hospital

140 total trials

What the Registry Record Tells You About NCT01701258

The ClinicalTrials.gov registry entry for NCT01701258 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01701258 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01701258 about?

NCT01701258 is a clinical study titled "An Investigation of Early Life Stress and Depression". 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 r...

What is the current status of trial NCT01701258?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2013-08. Estimated completion is 2017-05.

What interventions are being tested in trial NCT01701258?

The interventions under investigation include: Placebo (DRUG), Amisulpride (DRUG).

Who is sponsoring clinical trial NCT01701258?

This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.