A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder
Neural Correlates of Emotional Processing in Depressed and Remitted Bipolar and Unipolar Depressed Subjects: An fMRI Investigation
2 other identifiers
interventional
42
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 major-depressive-disorder
Started Feb 2005
Longer than P75 for phase_4 major-depressive-disorder
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFebruary 8, 2013
February 1, 2013
4.3 years
September 12, 2005
February 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
MRI Data - Acquired before and 1- 3- and 6- weeks after beginning pharmacotherapy.
6 weeks
17 Item - Hamilton Depression Rating Scale - Weekly
6 weeks
Clinical Global Impression - Improvement/Severity - Weekly
6 weeks
Young Mania Rating Scale - Weekly
6 weeks
Secondary Outcomes (6)
Positive Affect Negative Affect Scale
6 weeks
Beck Depression Inventory
6 weeks
State Trait Anxiety Index
6 weeks
Behavioural Activation/Inhibition Scale
6 weeks
SexFX Scale
6 weeks
- +1 more secondary outcomes
Study Arms (1)
Fluoxetine + Olanzapine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Eli Lilly and Companycollaborator
Study Sites (2)
University Health Network - Toronto General Division
Toronto, Ontario, M5G2C4, Canada
University Health Network - Toronto Western Division
Toronto, Ontario, M5T2S8, Canada
Related Publications (3)
Kumari V, Mitterschiffthaler MT, Teasdale JD, Malhi GS, Brown RG, Giampietro V, Brammer MJ, Poon L, Simmons A, Williams SC, Checkley SA, Sharma T. Neural abnormalities during cognitive generation of affect in treatment-resistant depression. Biol Psychiatry. 2003 Oct 15;54(8):777-91. doi: 10.1016/s0006-3223(02)01785-7.
PMID: 14550677BACKGROUNDMalhi GS, Lagopoulos J, Ward PB, Kumari V, Mitchell PB, Parker GB, Ivanovski B, Sachdev P. Cognitive generation of affect in bipolar depression: an fMRI study. Eur J Neurosci. 2004 Feb;19(3):741-54. doi: 10.1111/j.0953-816x.2003.03159.x.
PMID: 14984424BACKGROUNDDavidson RJ, Irwin W, Anderle MJ, Kalin NH. The neural substrates of affective processing in depressed patients treated with venlafaxine. Am J Psychiatry. 2003 Jan;160(1):64-75. doi: 10.1176/appi.ajp.160.1.64.
PMID: 12505803BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sidney H. Kennedy, MD, FRCPC
University Health Network, Department of Psychiatry, University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
February 1, 2005
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
February 8, 2013
Record last verified: 2013-02