Biomarkers for Outcomes In Late-life Depression (BOLD)

Exclusion Criteria

• •Subjects will have no unstable medical illness that would prevent completion of participation in the trial, determined as needed from physical examination, ECG, laboratory safety tests, as well as a review of systems
• •mentally or legally incapacitated, unable to give informed consent
• •meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features
• •MMSE (Folstein et al., 1975) score ≤ 24
• •evidence of drug dependency or substance abuse within the preceding nine months
• •stable and in remission on current psychotropic medication(s)
• •any ECT within the past six months
• •failure to tolerate ESC or treatment failure with an adequate trial of ESC in the current episode
• •ESC would be contraindicated (e.g., hyponatremia with a prior SSRI)
• •treatment with fluoxetine or an MAOI within the past four weeks
• •any medical illness severe enough to significantly affect brain function or to interfere with interpretation of study results
• •history of seizures, brain surgery, skull fracture, significant head trauma, or abnormal EEG
• •psychiatric hospitalization indicated (e.g., imminent danger to self or others)
• •initial QEEG recording is contaminated with artifact so that determination of the biomarker is precluded
• •use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines - same list as in BRITE-MD)