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fMRI Study of Treatment Changes in Major Depression

Primary Purpose

Major Depression, Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Cognitive Behavioral Therapy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Major Depression focused on measuring Major Depression, Functional Magnetic Resonance Imaging, Emotional Circuitry, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

DEPRESSED GROUP:

Inclusion criteria:

  1. Age 18-50
  2. DSM-IV criteria for major depressive disorder (MDD)
  3. Minimum Hamilton Rating Scale for Depression (HAMD) score > 18
  4. Right handed
  5. Capacity to give informed consent and follow study procedures
  6. English speaking

Exclusion criteria:

  1. Cannot give informed consent
  2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures
  3. Does not speak English
  4. Known primary neurological disorders
  5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
  6. MRI contraindications e.g. foreign metallic implants, pacemaker
  7. Known allergy or hypersensitivity to sertraline
  8. Active suicidality
  9. Severe or unstable medical illness or conditions or drugs that may cause depression
  10. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, psychotic features of depression, current obsessive compulsive disorder (OCD) or panic disorder. In general, subjects with a history of other Axis I disorders prior to their depression will be excluded.
  11. Current episode has failed to respond to adequate trials of two prior antidepressants for at least 6 weeks at therapeutic doses.
  12. Treatment with sertraline for at least one month in past 3 months.
  13. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.
  14. Current psychotherapy
  15. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.

CONTROL GROUP:

Inclusion criteria:

  1. Age 18-50
  2. No history of MDD
  3. HAMD score < 7
  4. Right handed
  5. Capacity to give informed consent and follow study procedures
  6. English speaking

Exclusion criteria:

  1. Cannot give informed consent
  2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures
  3. Does not speak English
  4. Known primary neurological disorders
  5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
  6. MRI contraindications e.g. foreign metallic implants, pacemaker
  7. Severe or unstable medical illness or conditions or drugs that may cause depression
  8. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, major depression, OCD or panic disorder.
  9. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.
  10. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Depressed Group: CBT

Healthy Control Group

Depressed Group: SRT

Arm Description

Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.

Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.

Depressed participants randomized to receive the antidepressant sertraline (SRT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.

Outcomes

Primary Outcome Measures

Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.
Hamilton Depression Rating Scale Score at Baseline and 12 Weeks
The patient was rated by a research team member among 17 dimensions/items pertaining to depression symptoms experienced over the last week. Each item is scored from 0 (=absent), up to 2 or 4 (depending on the item). The maximum total score on the assessment, indicating the most severe depression, would be 52. A total score of 0-7 is considered to be normal. Total scores of 20 or higher indicate moderate, severe, or very severe depression. A 50% or greater drop in Hamilton Depression Rating Scale signifies response to treatment.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2009
Last Updated
June 18, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01027559
Brief Title
fMRI Study of Treatment Changes in Major Depression
Official Title
fMRI Studies of Emotional Circuitry in Major Depression: Treatment Changes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT) has the same healing effect on the brain for people with depression as traditional antidepressants do, and in comparison to healthy controls with no history of depression, to find out more about the causes of depression including differences in the extent of problems caused by depression. We hypothesize that CBT will have the same healing effect on the brain as antidepressants; that differences in brain activations created by the various tasks and genetic differences will help us understand differences in the type and severity of symptoms among the depressed subjects.
Detailed Description
The overall purposes of this research are to determine if Cognitive Behavioral Therapy (CBT) has the same healing effect on the brain for people with depression as traditional antidepressants do, to find out more about the causes of depression and why people differ in the extent of problems caused by depression, and to determine if certain differences in genes within populations are related to clinical symptoms.Genes we are examining for this study are COMT, BDNF, and 5-HTT long arm and short arm, as well as future genes that may be discovered to play a role in depression at a later time, and will be determined by examining saliva and blood samples. We are primarily studying depression by functional Magnetic Resonance Imaging (fMRI) which allows us to identify certain parts of the brain that show how the brain works in controlling negative feelings. Participants will be imaged while performing different tasks that are believed to activate emotional circuitry of the brain. Comparisons of activation patterns across these tasks will be used to characterize the cognitive mechanisms supported by different cortical regions, and to determine patterns of functional brain deficits in subjects with depression. Comparisons will also be made between changes that occur after treatment with an approved antidepressant and treatment with CBT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Treatment
Keywords
Major Depression, Functional Magnetic Resonance Imaging, Emotional Circuitry, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depressed Group: CBT
Arm Type
Active Comparator
Arm Description
Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.
Arm Title
Healthy Control Group
Arm Type
No Intervention
Arm Description
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
Arm Title
Depressed Group: SRT
Arm Type
Active Comparator
Arm Description
Depressed participants randomized to receive the antidepressant sertraline (SRT) for treatment. A fMRI scan session will occur immediately prior to starting treatment, and their second fMRI scan will occur immediately following the completion of 12 weeks of therapy.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
SRT
Intervention Description
Depressed participants will be randomized to SRT or CBT treatment. For those in the SRT treatment condition, visits will involve dispensing medications, checking for side effects and administering the Hamilton Depression rating scale occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response. Depressed subjects will start their SRT treatment once their first MRI and computer testing sessions are completed.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
Depressed participants will be randomized to SRT or CBT treatment. For those in the CBT treatment condition, visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and administer the Hamilton Depression rating scale will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed subjects will start their CBT treatment once their first MRI and computer testing sessions are completed.
Primary Outcome Measure Information:
Title
Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
Description
MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.
Time Frame
baseline visit and 8-week follow-up
Title
Hamilton Depression Rating Scale Score at Baseline and 12 Weeks
Description
The patient was rated by a research team member among 17 dimensions/items pertaining to depression symptoms experienced over the last week. Each item is scored from 0 (=absent), up to 2 or 4 (depending on the item). The maximum total score on the assessment, indicating the most severe depression, would be 52. A total score of 0-7 is considered to be normal. Total scores of 20 or higher indicate moderate, severe, or very severe depression. A 50% or greater drop in Hamilton Depression Rating Scale signifies response to treatment.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DEPRESSED GROUP: Inclusion criteria: Age 18-50 DSM-IV criteria for major depressive disorder (MDD) Minimum Hamilton Rating Scale for Depression (HAMD) score > 18 Right handed Capacity to give informed consent and follow study procedures English speaking Exclusion criteria: Cannot give informed consent Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures Does not speak English Known primary neurological disorders Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic) MRI contraindications e.g. foreign metallic implants, pacemaker Known allergy or hypersensitivity to sertraline Active suicidality Severe or unstable medical illness or conditions or drugs that may cause depression Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, psychotic features of depression, current obsessive compulsive disorder (OCD) or panic disorder. In general, subjects with a history of other Axis I disorders prior to their depression will be excluded. Current episode has failed to respond to adequate trials of two prior antidepressants for at least 6 weeks at therapeutic doses. Treatment with sertraline for at least one month in past 3 months. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics. Current psychotherapy Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers. CONTROL GROUP: Inclusion criteria: Age 18-50 No history of MDD HAMD score < 7 Right handed Capacity to give informed consent and follow study procedures English speaking Exclusion criteria: Cannot give informed consent Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures Does not speak English Known primary neurological disorders Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic) MRI contraindications e.g. foreign metallic implants, pacemaker Severe or unstable medical illness or conditions or drugs that may cause depression Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, major depression, OCD or panic disorder. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette I Sheline, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Conway, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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fMRI Study of Treatment Changes in Major Depression

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