Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01701258
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 \[e.g., (meth)amphetamine), methylphenidate\].
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01701258
Study Brief:
Protocol Section:
NCT01701258