A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder
Major Depressive Disorder
About this trial
This is an interventional diagnostic trial for Major Depressive Disorder focused on measuring Magnetic Resonance Imaging, Diagnostic Imaging, Mood Disorders, Major Depressive Disorder, Antipsychotic, Olanzapine, Fluoxetine
Eligibility Criteria
Inclusion Criteria: (All three groups) age 18-55 years satisfactory physical health education level and a degree of understanding to communicate effectively with the investigator c capable of providing informed consent female subjects of childbearing potential, a medically accepted means of contraception. Additional inclusion criteria for the patient groups include DSM-IV-TR criteria for a diagnosis of BD or MDD currently meeting criteria for an MDE and a Hamilton Depression Rating Scale 17 Item (HDRS-17) score of > 17 blood indices within normal clinical ranges. Exclusion Criteria: (All three groups) DSM-IV-TR criteria for substance abuse or dependence (except nicotine or caffeine) within the past 6 months comorbid neurological or other major psychiatric disorders as defined in the DSM-IV-TR; history of neurological trauma resulting in loss of consciousness; uncorrected hypothyroidism or hyperthyroidism, including elevated thyroid stimulating hormone (TSH); other unstable medical condition; female subjects who are pregnant or nursing; Additional exclusion criteria for the BD and MDD group include: prior failure to respond to fluoxetine and olanzapine in combination at adequate dose and duration; evidence of serious risk of suicide based on clinician assessment and/or HRSD suicide item > 3; course of ECT (electroconvulsive therapy) in the preceding 6 months; Young Mania Rating Scale (YMRS) > 7; administration of fluoxetine within previous 4 weeks; treatment resistance as defined by the failure of two antidepressant trials from dissimilar classes Hyperglycemia or diabetes mellitus as defined by a fasting blood glucose value of > 125 mg/dl.
Sites / Locations
- University Health Network - Toronto General Division
- University Health Network - Toronto Western Division
Arms of the Study
Arm 1
Active Comparator
Fluoxetine + Olanzapine