Major Depressive Disorder
Conditions
Keywords
Magnetic Resonance Imaging, Diagnostic Imaging, Mood Disorders, Major Depressive Disorder, Antipsychotic, Olanzapine, Fluoxetine
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.
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 context of BD (n=15); MDD (n=15) and a group of psychiatrically unaffected control subjects (CS, n=15) will undergo four fMRI scans while experiencing a temporary mood induction through the presentation of affective imagery from the International Affective Picture System (IAPS). Both BD and MDD subjects will receive the same combination pharmacotherapy to treat the depression, with fMRI data acquired before, and 1, 3, 6 weeks following pharmacotherapy initiation. Positive, negative, and neutral affective visual stimuli will be presented in a blocked design. Comparison(s): The effects of time and group will be analyzed in factorial models. Regions of interest that demonstrate significant group-by-time interactions will be further correlated with self-report and clinician-rated psychometric indices.
Interventions
DRUGFluoxetine+Olanzapine
DRUGOlanzapine
PROCEDUREFunctional Magnetic Resonance Imaging
Sponsors
Eli Lilly and Company
University Health Network, Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| SexFX Scale | 6 weeks |
| Positive Affect Negative Affect Scale | 6 weeks |
| AMDP-5 Symptom Questionnaire | 6 weeks |
| Beck Depression Inventory | 6 weeks |
| State Trait Anxiety Index | 6 weeks |
| Behavioural Activation/Inhibition Scale | 6 weeks |
Countries
Canada
Outcome results
None listed