A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study employs functional magnetic resonance imaging to compare brain activation patterns during a depressive episode in patients diagnosed with bipolar disorder, major depressive disorder, and a group of healthy control subjects. Depressed patients will be treated with a combination of fluoxetine and olanzapine and undergo MRI scans before, during, and after pharmacotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Eli Lilly and Company
• Treatments: Fluoxetine; Olanzapine

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.