Phase 1
N=153
An Investigation of Early Life Stress and Depression
Major Depressive Disorder (MDD) · History of Childhood Sexual Abuse (CSA)
Bottom Line
View on ClinicalTrials.gov: NCT01701258 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Dopamine Active Transporter Binding Potential — 3.191; 3.161; 3.175; 3.216 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Amisulpride (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Mclean Hospital
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dopamine Active Transporter Binding Potential |
3.191; 3.161; 3.175; 3.216; 3.361; 3.359 | — |
| PRIMARY The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress |
0.028; 0.117; 0.092; 0.167; 0.124; 0.155 | — |
| PRIMARY The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress |
2.71; 4.75; 2.16; 4.15; 2.06; 4.99 | — |
| PRIMARY Cortisol Output in Response to a Stress Manipulation |
9.80; 12.53; 10.15; 14.19; 9.11; 12.28 | — |
| PRIMARY Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues |
.514; .054; .511; .079; .403; .608 | — |
| PRIMARY Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback |
-.101; .040; -.197; -.905; -.819; -.773 | — |
| PRIMARY The Effect of Diagnosis on Cortisol Reactivity |
156.58; 186.78; 152.13; 179.16 | — |
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.
Eligibility 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].
Data sourced from ClinicalTrials.gov (NCT01701258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.