CompletedPhase 1

An Investigation of Early Life Stress and Depression

United States153 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range

20 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

General Inclusion Criteria: * Females of all ethnic origins, age between 20 and 45; right-handed (Chapman \& Chapman 1987); * Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants); Inclusion Criteria for Childhood Sexual Abuse/MDD (CSA/MDD) Group: * At least one incident of contact sexual abuse1 between the ages 5-14 years; * Current DSM-IV diagnostic criteria for MDD (as diagnosed with the use of the SCID); Inclusion Criteria for Childhood Sexual Abuse/Resilient (CSA/RES) Group: * At least one incident of contact sexual abuse1 between the ages 5-14 years; * Absence of past or current DSM diagnosis, including MDD or alcohol/substance abuse; Inclusion Criteria for Non-traumatized, MDD (MDD) Group: * No incidents of sexual, verbal, or physical abuse (ascertained using the Traumatic Antecedents Questionnaire); * Current DSM-IV diagnostic criteria for MDD (as diagnosed with the use of SCID); Non-traumatized, healthy controls (controls): * No incidents of sexual, verbal, or physical abuse (ascertained using the Traumatic Antecedents Questionnaire); * Absence of any medical, neurological, and psychiatric illness (including alcohol/substance abuse) Exclusion Criteria: * Participants with suicidal ideation where study participation is deemed unsafe by the study clinician; * Pregnant women or women of childbearing potential who are not compliant wit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dopamine Active Transporter Binding Potential

Timeframe: 1 hour PET scan (Session 3)

The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress

Timeframe: 3 hour EEG Session (Session 4)

The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress

Timeframe: 3 hour EEG Session (Session 4)

Cortisol Output in Response to a Stress Manipulation

Timeframe: 3 hour EEG Session (Session 4)

Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues

Timeframe: 3 hour Drug & fMRI Session (Session 2)

Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback

Timeframe: 3 hour Session 2 (fMRI session)

Trial details

NCT IDNCT01701258

SponsorMclean Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2018-03-21

View on ClinicalTrials.gov More Major Depressive Disorder (MDD) trials

Plain-language summary

Who can participate

Age range

20 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dopamine Active Transporter Binding Potential

Timeframe: 1 hour PET scan (Session 3)

The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress

Timeframe: 3 hour EEG Session (Session 4)

The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress

Timeframe: 3 hour EEG Session (Session 4)

Cortisol Output in Response to a Stress Manipulation

Timeframe: 3 hour EEG Session (Session 4)

Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues

Timeframe: 3 hour Drug & fMRI Session (Session 2)

Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback

Timeframe: 3 hour Session 2 (fMRI session)