Major DepressionNCT01027559
fMRI Study of Treatment Changes in Major Depression
A study testing Sertraline and Cognitive Behavioral Therapy in people with Major Depression and Treatment, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Treatment
- What is being tested?
- Sertraline and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- Age 18-50
- No history of MDD
- HAMD score < 7
- Right handed
- Capacity to give informed consent and follow study procedures
- English speaking
Who cannot join
- 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
Show all 26Show fewer
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depression, Treatment
- Being tested
- Sertraline, Cognitive Behavioral Therapy
- Keywords
- Major Depression, Functional Magnetic Resonance Imaging, Emotional Circuitry, Cognitive Behavioral Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called SRT
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.
Cognitive Behavioral TherapyBehavioural
Also called CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Depressed Group: CBT | Active comparator | 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. Receives: Behavioral: Cognitive Behavioral Therapy |
| Healthy Control Group | No intervention | Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after. |
| Depressed Group: SRT | Active comparator | 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. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline visit and 8-week follow-up
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Yvette I Sheline, MD, Principal investigator, University of PennsylvaniaCharles Conway, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027559
- Sponsor's protocol ID
- 081348
- Other IDs
- R01MH064821, 2R01MH064821-05A2, DDTR A3-NSI
- Status last verified
- Jun 2018
- First submitted
- 4 Dec 2009
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Studies of Emotional Circuitry in Major Depression: Treatment Changes
- ClinicalTrials.gov ID
- NCT01027559
- Acronym / sponsor ID
- 081348
- Conditions
- Major Depression, Treatment
- Keywords
- Major Depression, Functional Magnetic Resonance Imaging, Emotional Circuitry, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Dec 2009 (estimated)
- Results
- Posted 13 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depressed Group: CBT | Active comparator | Behavioral: Cognitive Behavioral TherapyDepressed 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 Control Group | No intervention | –Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after. |
| Depressed Group: SRT | Active comparator | Drug: SertralineDepressed 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: SRTDepressed 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. | Drug | Depressed Group: SRT |
| Cognitive Behavioral TherapyAlso: CBTDepressed 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. | Behavioural | Depressed Group: CBT |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvette I Sheline, MD principal investigator
University of Pennsylvania
Charles Conway, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline and Cognitive Behavioral Therapy in people with Major Depression and Treatment, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.