An Investigation of Early Life Stress and Depression

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mclean Hospital
• Collaborators: Massachusetts General Hospital; National Institute of Mental Health (NIMH)
• Treatments: Amisulpride; Sulpiride; Sultopride

Criteria

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 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].