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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188942
First Posted: September 16, 2005
Last Update Posted: February 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Sidney Kennedy, University Health Network, Toronto
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder Drug: Fluoxetine+Olanzapine Drug: Olanzapine Procedure: Functional Magnetic Resonance Imaging Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neural Correlates of Emotional Processing in Depressed and Remitted Bipolar and Unipolar Depressed Subjects: An fMRI Investigation

Resource links provided by NLM:


Further study details as provided by Sidney Kennedy, University Health Network, Toronto:

Primary Outcome Measures:
  • MRI Data - Acquired before and 1- 3- and 6- weeks after beginning pharmacotherapy. [ Time Frame: 6 weeks ]
  • 17 Item - Hamilton Depression Rating Scale - Weekly [ Time Frame: 6 weeks ]
  • Clinical Global Impression - Improvement/Severity - Weekly [ Time Frame: 6 weeks ]
  • Young Mania Rating Scale - Weekly [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Positive Affect Negative Affect Scale [ Time Frame: 6 weeks ]
  • Beck Depression Inventory [ Time Frame: 6 weeks ]
  • State Trait Anxiety Index [ Time Frame: 6 weeks ]
  • Behavioural Activation/Inhibition Scale [ Time Frame: 6 weeks ]
  • SexFX Scale [ Time Frame: 6 weeks ]
  • AMDP-5 Symptom Questionnaire [ Time Frame: 6 weeks ]

Enrollment: 42
Study Start Date: February 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluoxetine + Olanzapine Drug: Fluoxetine+Olanzapine Drug: Olanzapine Procedure: Functional Magnetic Resonance Imaging

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188942


Locations
Canada, Ontario
University Health Network - Toronto General Division
Toronto, Ontario, Canada, M5G2C4
University Health Network - Toronto Western Division
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Eli Lilly and Company
Investigators
Principal Investigator: Sidney H. Kennedy, MD, FRCPC University Health Network, Department of Psychiatry, University of Toronto
  More Information

Publications:
Responsible Party: Sidney Kennedy, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188942     History of Changes
Other Study ID Numbers: UHN REB 04-0204-B
CTA Control #095694
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by Sidney Kennedy, University Health Network, Toronto:
Magnetic Resonance Imaging
Diagnostic Imaging
Mood Disorders
Major Depressive Disorder
Antipsychotic
Olanzapine
Fluoxetine

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Olanzapine
Fluoxetine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors