Current Major Depressive DisorderNCT00071123
Evaluating Brain Responses to Facial Expressions in Major Depressive Disorder
An observational study of Current Major Depressive Disorder and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will evaluate emotional processing biases in the brain while viewing facial expressions in adults with current or remitted major depressive disorder and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Current Major Depressive Disorder, Healthy, Remitted Major Depressive Disorder
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2003to 15 Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers (n=65)
- Healthy Control Sample (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): Right-handed subjects (ages 18-55) will be selected who have not met criteria for any major psychiatric disorder, have no known first-degree relatives with mood disorders, and have a current score on the Hamilton Depression Rating Scale (HDRS; 17 item) in the not depressed range (less than or equal to 7). Control subjects will be matched to depressed subjects for age, gender, and education.
- MDD Samples (n =80)
- MDD Sample-Currently Depressed (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): Right-handed subjects (ages 18-55) will be selected with primary MDD currently depressed by DSM-IV criteria for recurrent MDD and current HDRS score in the moderately-to-severely depressed range (greater than or equal to 18).
- MDD Sample-Remitted Depressed (n = 15, phase 2): Right-handed subjects (ages 18-50) will be selected with a past history of MDD by DSM-IV criteria.
- Healthy Relatives of MDD Subjects (n=45)
- Right-handed subjects (ages 18-55) will be selected who have a first-degree relative with MDD but do not themselves meet criteria for a psychiatric disorder. Subjects will be matched to depressed and control subjects for age, gender, and education.
Who cannot join
- Subjects will be recruited who are drug-na ve or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. Effective medications will not be discontinued for the purposes of the study. Subjects will also be excluded if they have a) serious suicidal ideation or behavior, b) psychosis to the extent that the ability to provide informed consent is in doubt, c) medical conditions or concomitant medications (see Appendix III) that are likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases, d) a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM-IV criteria), e) current pregnancy (as documented by pregnancy testing prior to scanning), f) general MRI exclusion criteria, g) history of non-response to Zoloft or of intolerable or adverse side effects during Zoloft treatment. Additional exclusion criteria applied to control subjects are: a) subjects with a current or past history of other axis I psychiatric conditions, b) subjects with first-degree family members with current or past history of mood disorder.
- Subjects beyond age 55 are excluded to reduce the biological heterogeneity encompassed by the MDD criteria, and to reduce the variability of the BOLD signal. Subjects whose first major depressive episodes arose temporally after other major medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary MDD.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Functional Neuroanatomy of Emotion Regulation in Major Depressive Disorder (MDD)
This study will evaluate emotional processing biases in the brain while viewing facial expressions in adults with current or remitted major depressive disorder and healthy volunteers.
Read the detailed description
The goal of this research is to elucidate the neurophysiological abnormalities associated with processing emotionally valenced stimuli in MDD. Neuroimaging technology has led to the identification of specific abnormalities in the amygdala, ventral striatum and medial prefrontal cortex in response to affective pictures. Much of the knowledge involving these structures in emotion processing has been elucidated through animal models including classical fear conditioning and reversal-learning paradigms. Functional magnetic resonance imaging (fMRI) studies have applied similar techniques in humans to study emotional processing. The amygdala has been shown to play a role in the learning of fear (aversive) conditioning to emotional stimuli, the ventral striatum has been shown to play a role in appetitive conditioning, and areas of the prefrontal cortex are recruited for extinction of conditioned responses. These areas have also been implicated as key structures in the abnormal expression of emotion in MDD. Dysregulation of connections between the amygdala and prefrontal cortex has been hypothesized to influence depressed subjects' tendency to ruminate on emotional events and memories, which may be associated with an inability to properly regulate emotional processing through habituation and extinction mechanisms. Research suggests that depressed individuals have an impaired ability to disengage from or habituate to emotional stimuli perceived as sad.
In addition to studying emotional processing at a conscious, cortical level, significant evidence suggests that many aspects of emotional processing occur below conscious awareness, at a preconscious level. The technique of backward masking assesses the automaticity of emotional processing and responses to affective stimuli. In MDD, backward masking serves to avoid confounding interpretation by the presence of other cognitive processing, which may result from depressed subjects perseverating on emotional stimuli. The proposed study builds on previous fMRI research to investigate neurophysiological differences in the processing of aversively conditioned emotional stimuli in depressed compared to healthy individuals. Using fMRI technology and a variation of the paradigm developed by Morris et al., subjects with MDD will be classically conditioned to the presence of an unmasked specific target face (angry or sad) and the subsequent neural responses to the stimuli will be assessed utilizing the backward masking technique. The BOLD hemodynamic response and rates of habituation and extinction to the faces will be compared between depressed subjects with MDD and healthy controls, currently depressed versus currently remitted subjects with MDD, and MDD subjects pre- and post-antidepressant therapy.
The present amendment proposes to include an additional paradigm in the testing battery. This new paradigm has been extensively examined under different pharmacological manipulations, and in healthy individuals undergoing fMRI but has yet to be examined in patient populations. The task complements the paradigms presently included by extending the research to encompass appetitive as well as aversive emotional processing.
This research will be used to evaluate neural processes involved in emotional dysregulation in MDD and may direct future research to potential therapeutic approaches for the treatment of mood and anxiety disorders with abnormalities in emotional processing.
- Keywords
- fMRI, Habituation, Extinction, Amygdala, Emotion, Major Depressive Disorder, Medial Prefrontal Cortex, Backward Masking, Depression, MDD, Healthy Volunteer, HV
- Medical subject headings
- Substance-Related Disorders, Depressive Disorder, Major, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study start9 Oct 2003
- Study completion15 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Current Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Observational
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071123
- Sponsor's protocol ID
- 040002
- Other IDs
- 04-M-0002
- Status last verified
- 15 Nov 2010
- First submitted
- 10 Oct 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Morris JS, Buchel C, Dolan RJ. Parallel neural responses in amygdala subregions and sensory cortex during implicit fear conditioning. Neuroimage. 2001 Jun;13(6 Pt 1):1044-52. doi: 10.1006/nimg.2000.0721.
PubMed 11352610Cahill L, Haier RJ, White NS, Fallon J, Kilpatrick L, Lawrence C, Potkin SG, Alkire MT. Sex-related difference in amygdala activity during emotionally influenced memory storage. Neurobiol Learn Mem. 2001 Jan;75(1):1-9. doi: 10.1006/nlme.2000.3999.
PubMed 11124043Drevets WC. Prefrontal cortical-amygdalar metabolism in major depression. Ann N Y Acad Sci. 1999 Jun 29;877:614-37. doi: 10.1111/j.1749-6632.1999.tb09292.x.
PubMed 10415674
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Neuroanatomy of Emotion Regulation in Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT00071123
- Acronym / sponsor ID
- 040002
- Keywords
- fMRI, Habituation, Extinction, Amygdala, Emotion, Major Depressive Disorder, Medial Prefrontal Cortex, Backward Masking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 9 Oct 2003
- Study completion
- 15 Nov 2010
- First posted
- 13 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate emotional processing biases in the brain while viewing facial expressions in adults with current or remitted major depressive disorder and healthy volunteers.
Detailed description
The goal of this research is to elucidate the neurophysiological abnormalities associated with processing emotionally valenced stimuli in MDD. Neuroimaging technology has led to the identification of specific abnormalities in the amygdala, ventral striatum and medial prefrontal cortex in response to affective pictures. Much of the knowledge involving these structures in emotion processing has been elucidated through animal models including classical fear conditioning and reversal-learning paradigms. Functional magnetic resonance imaging (fMRI) studies have applied similar techniques in humans to study emotional processing. The amygdala has been shown to play a role in the learning of fear (aversive) conditioning to emotional stimuli, the ventral striatum has been shown to play a role in appetitive conditioning, and areas of the prefrontal cortex are recruited for extinction of conditioned responses. These areas have also been implicated as key structures in the abnormal expression of emotion in MDD. Dysregulation of connections between the amygdala and prefrontal cortex has been hypothesized to influence depressed subjects' tendency to ruminate on emotional events and memories, which may be associated with an inability to properly regulate emotional processing through habituation and extinction mechanisms. Research suggests that depressed individuals have an impaired ability to disengage from or habituate to emotional stimuli perceived as sad.
In addition to studying emotional processing at a conscious, cortical level, significant evidence suggests that many aspects of emotional processing occur below conscious awareness, at a preconscious level. The technique of backward masking assesses the automaticity of emotional processing and responses to affective stimuli. In MDD, backward masking serves to avoid confounding interpretation by the presence of other cognitive processing, which may result from depressed subjects perseverating on emotional stimuli. The proposed study builds on previous fMRI research to investigate neurophysiological differences in the processing of aversively conditioned emotional stimuli in depressed compared to healthy individuals. Using fMRI technology and a variation of the paradigm developed by Morris et al., subjects with MDD will be classically conditioned to the presence of an unmasked specific target face (angry or sad) and the subsequent neural responses to the stimuli will be assessed utilizing the backward masking technique. The BOLD hemodynamic response and rates of habituation and extinction to the faces will be compared between depressed subjects with MDD and healthy controls, currently depressed versus currently remitted subjects with MDD, and MDD subjects pre- and post-antidepressant therapy.
The present amendment proposes to include an additional paradigm in the testing battery. This new paradigm has been extensively examined under different pharmacological manipulations, and in healthy individuals undergoing fMRI but has yet to be examined in patient populations. The task complements the paradigms presently included by extending the research to encompass appetitive as well as aversive emotional processing.
This research will be used to evaluate neural processes involved in emotional dysregulation in MDD and may direct future research to potential therapeutic approaches for the treatment of mood and anxiety disorders with abnormalities in emotional processing.
Study design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy Volunteers (n=65)
- Healthy Control Sample (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): Right-handed subjects (ages 18-55) will be selected who have not met criteria for any major psychiatric disorder, have no known first-degree relatives with mood disorders, and have a current score on the Hamilton Depression Rating Scale (HDRS; 17 item) in the not depressed range (less than or equal to 7). Control subjects will be matched to depressed subjects for age, gender, and education.
- MDD Samples (n =80)
- MDD Sample-Currently Depressed (n = 30, phase 1; n = 15, phase 3; n=20, phase 5): Right-handed subjects (ages 18-55) will be selected with primary MDD currently depressed by DSM-IV criteria for recurrent MDD and current HDRS score in the moderately-to-severely depressed range (greater than or equal to 18).
- MDD Sample-Remitted Depressed (n = 15, phase 2): Right-handed subjects (ages 18-50) will be selected with a past history of MDD by DSM-IV criteria.
Key exclusion criteria (2 listed)
- Subjects will be recruited who are drug-na ve or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. Effective medications will not be discontinued for the purposes of the study. Subjects will also be excluded if they have a) serious suicidal ideation or behavior, b) psychosis to the extent that the ability to provide informed consent is in doubt, c) medical conditions or concomitant medications (see Appendix III) that are likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases, d) a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM-IV criteria), e) current pregnancy (as documented by pregnancy testing prior to scanning), f) general MRI exclusion criteria, g) history of non-response to Zoloft or of intolerable or adverse side effects during Zoloft treatment. Additional exclusion criteria applied to control subjects are: a) subjects with a current or past history of other axis I psychiatric conditions, b) subjects with first-degree family members with current or past history of mood disorder.
- Subjects beyond age 55 are excluded to reduce the biological heterogeneity encompassed by the MDD criteria, and to reduce the variability of the BOLD signal. Subjects whose first major depressive episodes arose temporally after other major medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary MDD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11352610Morris JS, Buchel C, Dolan RJ. Parallel neural responses in amygdala subregions and sensory cortex during implicit fear conditioning. Neuroimage. 2001 Jun;13(6 Pt 1):1044-52. doi: 10.1006/nimg.2000.0721.
- Background: PubMed 11124043Cahill L, Haier RJ, White NS, Fallon J, Kilpatrick L, Lawrence C, Potkin SG, Alkire MT. Sex-related difference in amygdala activity during emotionally influenced memory storage. Neurobiol Learn Mem. 2001 Jan;75(1):1-9. doi: 10.1006/nlme.2000.3999.
- Background: PubMed 10415674Drevets WC. Prefrontal cortical-amygdalar metabolism in major depression. Ann N Y Acad Sci. 1999 Jun 29;877:614-37. doi: 10.1111/j.1749-6632.1999.tb09292.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Current Major Depressive Disorder and Healthy, run by National Institute of Mental Health (NIMH) 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 7 inclusion and 2 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 2 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071123, which also lists 3 linked publications.
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 2 Jul 2017.