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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00685334
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV criteria for AN (DSM-IV criteria for amenorrhea will not be strictly applied, as these patients have been shown to be clinically indistinguishable from those with full criteria AN)
* Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2 (BMI of 19 is equivalent to approximately 85% of ideal body weight \[IBW\] according to Metropolitan Life standards, and BMI of 14 is equivalent to approximately 65% IBW)
* Unwilling to pursue inpatient treatment if BMI is less than 18 kg/m2
* Free of psychotropic (e.g., antidepressant, antianxiety, mood stabilizer, antipsychotic) medication for 2 weeks before study entry (free for 4 weeks before study entry if taking fluoxetine or antipsychotic medications)
* Prior treatment of AN
Exclusion Criteria:
* Any medical or psychiatric problem requiring urgent clinical attention (e.g., metabolic disturbance, acute suicidality) and/or significant comorbid illnesses that are not likely to benefit from proposed treatments
* Significant orthostatic high blood pressure (systolic change greater than 30 mmHg upon changing from supine to standing position)
* Allergy to olanzapine or aripiprazole
* Commencing psychotherapy in the community within 3 months of study entry
* Diabetes mellitus, with fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose less than 140 mg/dL
* Known history of current or past jaundice
* Known history of narrow angle glaucoma
* Active substance abuse or dependence
* Schizophrenia, schizophreniform disorder, or bipolar illness
* Movement disorder or presence of tics
* History of tardive dyskinesia
* History of seizures
* Pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00685334
Study Brief:
Protocol Section:
NCT00685334