search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Fluoxetine+Olanzapine
Olanzapine
Functional Magnetic Resonance Imaging
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Active Comparator

Arm Label

Fluoxetine + Olanzapine

Arm Description

Outcomes

Primary Outcome Measures

MRI Data - Acquired before and 1- 3- and 6- weeks after beginning pharmacotherapy.
17 Item - Hamilton Depression Rating Scale - Weekly
Clinical Global Impression - Improvement/Severity - Weekly
Young Mania Rating Scale - Weekly

Secondary Outcome Measures

Positive Affect Negative Affect Scale
Beck Depression Inventory
State Trait Anxiety Index
Behavioural Activation/Inhibition Scale
SexFX Scale
AMDP-5 Symptom Questionnaire

Full Information

First Posted
September 12, 2005
Last Updated
February 6, 2013
Sponsor
University Health Network, Toronto
Collaborators
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00188942
Brief Title
A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder
Official Title
Neural Correlates of Emotional Processing in Depressed and Remitted Bipolar and Unipolar Depressed Subjects: An fMRI Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Magnetic Resonance Imaging, Diagnostic Imaging, Mood Disorders, Major Depressive Disorder, Antipsychotic, Olanzapine, Fluoxetine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine + Olanzapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fluoxetine+Olanzapine
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Procedure
Intervention Name(s)
Functional Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
MRI Data - Acquired before and 1- 3- and 6- weeks after beginning pharmacotherapy.
Time Frame
6 weeks
Title
17 Item - Hamilton Depression Rating Scale - Weekly
Time Frame
6 weeks
Title
Clinical Global Impression - Improvement/Severity - Weekly
Time Frame
6 weeks
Title
Young Mania Rating Scale - Weekly
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Positive Affect Negative Affect Scale
Time Frame
6 weeks
Title
Beck Depression Inventory
Time Frame
6 weeks
Title
State Trait Anxiety Index
Time Frame
6 weeks
Title
Behavioural Activation/Inhibition Scale
Time Frame
6 weeks
Title
SexFX Scale
Time Frame
6 weeks
Title
AMDP-5 Symptom Questionnaire
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidney H. Kennedy, MD, FRCPC
Organizational Affiliation
University Health Network, Department of Psychiatry, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network - Toronto General Division
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
University Health Network - Toronto Western Division
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
14550677
Citation
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.
Results Reference
background
PubMed Identifier
14984424
Citation
Malhi 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.
Results Reference
background
PubMed Identifier
12505803
Citation
Davidson 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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs