- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01027559
fMRI Study of Treatment Changes in Major Depression
June 18, 2018 updated by: Washington University School of Medicine
fMRI Studies of Emotional Circuitry in Major Depression: Treatment Changes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Depressed Group: CBT
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.
|
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.
Other Names:
|
No Intervention: Healthy Control Group
Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
|
|
Active Comparator: Depressed Group: SRT
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.
Time Frame: baseline visit and 8-week follow-up
|
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.
|
baseline visit and 8-week follow-up
|
Hamilton Depression Rating Scale Score at Baseline and 12 Weeks
Time Frame: 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.
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yvette I Sheline, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
December 4, 2009
First Submitted That Met QC Criteria
December 4, 2009
First Posted (Estimate)
December 8, 2009
Study Record Updates
Last Update Posted (Actual)
July 17, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- 081348
- R01MH064821 (U.S. NIH Grant/Contract)
- 2R01MH064821-05A2 (U.S. NIH Grant/Contract)
- DDTR A3-NSI (Other Grant/Funding Number: National Institute of Mental Health)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depression
-
Centre Hospitalier Universitaire de BesanconH. Lundbeck A/SCompletedResistant Major DepressionFrance
-
Stanford UniversityTerminatedMajor Depressive Disorder | Major Depressive Episode | Major Depressive Disorder, Recurrent | Major Depression Mild | Major Depression Moderate | Major Depression SevereUnited States
-
Hawler Medical UniversityCompleted
-
First Affiliated Hospital of Zhejiang UniversityNot yet recruiting
-
University of PittsburghCompletedPostpartum Major DepressionUnited States
-
Si TianmeiUnknownMajor Depression DisorderChina
-
The Hong Kong Polytechnic UniversityNot yet recruitingHealthy | Major Depression in Remission
-
AstraZenecaCompletedNon-psychotic Unipolar Major DepressionArgentina
-
Ruijin HospitalTerminatedTreatment Resistant Major Depression DisorderChina
-
Zentrum für Integrative PsychiatrieGerman Research FoundationCompletedCognitive Performance in Major DepressionGermany
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
University of PittsburghCompletedDepression | Anxiety | Sickle Cell DiseaseUnited States