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:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT00025857
Eligibility Criteria:
* INCLUSION CRITERIA:
All subjects 7-18 (adolescents).
Consent: can give consent/assent.
IQ: all subjects will have IQ greater than 70.
Subjects currently on antidepressants or benzodiazepines medication.
Subjects suffering from ADHD and currently on stimulants.
SUBJECTS WITH MAJOR DEPRESSION:
Diagnosis: Current diagnosis of MDD.
Clinical Impairment: CGAS less than 60.
SUBJECTS WITH PTSD:
Diagnosis: current diagnosis of PTSD.
Clinical Impairment: CGAS of less than 60.
SUBJECTS WITH HISTORY OF TRAUMA:
Trauma (i.e., sexual or physical abuse, exposure to an accident, etc.) will be defined according to the KSADS, the Child Trauma Questionnaire, the Life Events Survey and the history of adoption.
EXCLUSION CRITERIA:
Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign material in eye).
Any medical condition that increases risk for fluoxetine treatment for patients with MDD/PTSD.
Pregnancy.
Participants suffering from acute psychosis or suicidal ideation; current abuse/dependency to alcohol or drugs.
Currently in an abusive situation at home.
Weight that is 15% more or less than ideal body weight for sex and height.
Current tobacco use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT00025857
Study Brief:
Protocol Section:
NCT00025857