An Investigation of Early Life Stress and Depression

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There were four groups of subjects: those with a history of child sexual abuse that are currently experiencing a major depressive episode, those with a history of child sexual abuse without a current or past diagnosis of major depressive disorder, those without a history of child sexual abuse that are currently experiencing a major depressive episode, and those with without a history of child sexual abuse and without a current or past diagnosis of major depressive disorder. Within each group, half of the subjects were assigned to receive the study drug (amisulpride) and half to receive a placebo for the fMRI session (session 2 or 3).

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single-dose placebo capsule during the fMRI session only

Interventions

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Amisulpride

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

Intervention Type DRUG

Placebo

single-dose placebo capsule during the fMRI session only

Intervention Type DRUG

Other Intervention Names

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Solian

Eligibility Criteria

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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);

* 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);

* 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;

* 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 with the requirements of a urine and blood pregnancy test.
* Failure to meet MRI or PET safety requirements.
* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine (hypothyroidism), neurologic or hematologic disease;
* Past/current DSM diagnosis of: OCD, ADHD, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, mood congruent/incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion);
* Simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to MDD and only in the CSA/MDD and MDD groups (which will be matched for comorbidities);
* History of seizure disorder; renal insufficiency; history of adverse reactions to amisulpride;
* History of cocaine, stimulant, and other DA drug use \[e.g., (meth)amphetamine), methylphenidate\].

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes