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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01728194
Eligibility Criteria:
Inclusion Criteria:
* Age: 60-85 years, right-handed;
* Diagnosis: Major depression, unipolar (by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)IV (SCID-R) and DSM-IV criteria);
* Age of onset of first episode ≥ 50 years with up to three depressive episodes;
* Severity of depression: A 24-Item Hamilton Depression Rating Scale (HDRS) ≥ 20.
Exclusion Criteria:
* Psychotic depression by DSM-IV, i.e., presence of delusions with a SCID-R score higher than 2;
* High suicide risk, i.e. intent or plan to attempt suicide in near future;
* Presence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse;
* History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);
* Dementia: Diagnosis of dementia by DSM-IV;
* Mild Cognitive Impairment (MCI);
* Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or use of drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;
* Neurological brain disease and/or history of electroconvulsive therapy;
* History of any use of citalopram or escitalopram during the current episode or need for drugs that may interact with these agents, i.e. drug metabolized by the 2D6 P450 isoenzyme system;
* Current involvement in psychotherapy;
* Contraindications to MRI scanning including cardiac pacemaker, metallic objects and metallic implants contraindicating MRI, cardiac stent, claustrophobia;
* Inability to speak English;
* Corrected visual acuity \< 20/70; Color blindness.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT01728194
Study Brief:
Protocol Section:
NCT01728194