Status:
COMPLETED
A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The purpose of this study is to further characterize the neural correlates of affective processing in BD and MDD subjects using fMRI. Subjects who meet criteria for a major depressive episode in the c...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00188942
Start Date
February 1 2005
End Date
June 1 2009
Last Update
February 8 2013
Active Locations (2)
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1
University Health Network - Toronto General Division
Toronto, Ontario, Canada, M5G2C4
2
University Health Network - Toronto Western Division
Toronto, Ontario, Canada, M5T2S8