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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT02033369
Eligibility Criteria:
Inclusion Criteria:
* Weight between 44 kg and 115 kg
* Meets DSM-IV criteria for principal diagnosis of MDD, current major depressive episode, without psychotic features
* Score of \>16 and \<29 on 17-item Hamilton Rating Scale for Depression
* Psychotropic-naïve, as defined by lifetime \<2 weeks treatment with antidepressants, anxiolytics or antipsychotics
* Able to tolerate a treatment-free period during study participation
* Able to provide informed consent
Exclusion Criteria:
* A principal diagnosis of any current Axis I psychiatric disorder other than the MDD
* Lifetime diagnosis of any psychotic disorder, bipolar disorder, mental retardation, attention deficit/hyperactivity disorder, or substance use disorders (including nicotine use disorders)
* Serious suicidal risk or history of violent behavior which would make participation in the protocol unsafe
* Any tobacco use in the prior three months (if not already excluded for abuse/dependence by #1)
* Illicit drug use in the prior three months, as evidenced by history or urine toxicology screen
* Women who are pregnant, nursing, postmenopausal, or using hormonal methods of birth control
* Women who are not using an effective birth control method or sexual abstinence during the ten days before the scan
* Any medical or neurological problem that might affect interpretation of findings or safety of participation (e.g., blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, malignancy, neurological diseases of the brain, history of seizures or head trauma), low hemoglobin (Hb \< 12 gm/dL in males, Hb \< 10.5 gm/dL in females))
* Blood donation within 4 weeks of study
* Metal implants or paramagnetic objects in the body that might affect safety of undergoing MRI (e.g., heart pacemaker, shrapnel, bullets, surgical prostheses or surgical clips), as determined in consultation with a neuroradiologist and according to the guidelines set forth in the reference: "Guide to MR procedures and metallic objects" Shellock; Lippincott Williams and Wilkins, NY, 2001
* More than one major risk factor for coronary artery disease (e.g. hyperlipidemia, sedentary lifestyle). Smokers are already excluded by #4 above, and diabetics by #8 above
* Systolic blood pressure \> 140 or diastolic blood pressure \> 90 based on at least two readings at rest
* History of untoward reaction to amphetamine or other stimulant medication, or pramipexole
* Any psychotropic treatment in the past 3 weeks (or depot medication in the past 6 months), except for lorazepam,which may be administered as needed prior to imaging day
* Current, past or anticipated exposure to radiation in the workplace, or participation in nuclear medicine procedures, including research protocols (In case of previous exposure to activity due to research studies, subjects will be eligible if all conditions listed below are fulfilled: 1) The injected dose and dosimetry of the radiotracer are known; 2) Except for research studies, the subject has not been exposed to radiation (workplace and medical); 3) Adding prior exposure to the exposure due to the study will result in a yearly cumulative exposure lower than the FDA limit for research studies
* Family history of schizophrenia in parents, siblings, or children
* Ongoing cognitive-behavioral or interpersonal psychotherapy for depression (Supportive therapy is not an exclusion)
* Ongoing treatment with cimetidine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02033369
Study Brief:
Protocol Section:
NCT02033369