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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT01920802
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the ages of 18-35 with no history of any Axis-I diagnosis
* Does not meet criteria for substance abuse or dependence in the past six months
* Female subjects will use barrier-method, non-hormonal contraception
* Capacity to understand all the relevant risks and potential benefits of the study (informed consent)
* Must be able to speak and read English
Exclusion Criteria:
* Current or past Axis I psychiatric diagnosis, including alcohol or substance abuse or dependence (except nicotine or caffeine), but not including minor Axis I disorders (e.g. simple phobia)
* Lifetime use of psychotropic medications, including antipsychotics, antidepressants, mood stabilizers, and anxiolytics
* Presence or history of medical or neurological illness that, in the judgment of the investigator, could influence the results of the study
* Diagnosis of diabetes, hemoglobin A1C \> 6.5, hypertension, or dyslipidemias, or elevated random or fasting glucose, abnormal lipid levels, BP 130/85
* BMI 25 or \< 19, history of BMI \>35, and/or waist circumference \>35 inches for females, 40 inches for males
* Subjects who are pregnant or breast-feeding or planning to become pregnant during the study
* Acute suicidality
* Meets criteria for a Diagnostic and Statistical Manual, Version 4 (DSM-IV) defined eating disorder
* Use of, or clinical indication for, one or more of the following medications: lithium, anti-epileptic medication, steroids (oral or inhaled), stimulants, serotonin reuptake inhibitors, mirtazapine, tricyclic antidepressants, thyroid supplementation, sibutramine, metformin, thiazolidinediones, beta-blockers, clonidine, niacin
* Subjects who have had \>10% change in their body weight within the three months prior to enrollment
* HIV positive subjects
* Presence of mental retardation or pervasive developmental disorder
* History of recent (within 6 months) significant self-injurious behavior or violence
* Daily multivitamin or B-complex vitamin use
* A known history of dieting and difficulty with weight loss
* A strong family history of diabetes and/or heart disease
* History of congenital long QT syndrome or prolonged corrected QT interval (QTc) on screening EKG (\>450ms)
* Concomitant use of any medication that inhibits 2D6 or 3A4 metabolism
* Low serum potassium or magnesium
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01920802
Study Brief:
Protocol Section:
NCT01920802