DepressionNCT02658617
Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine
An observational study of Depression, run by Heinz Boeker.
Trial summary
The findings may guide future investigations on novel therapeutic targets in depressive subjects. Based on the depicted link between personality traits and altered brain metabolism and function, the latter might be used as supporting objective measures and possible biomarkers for increased depression risk. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Sep 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with an acute depressive episode (n = 20; 10 females; mean age ± SD age, 32.2 ± 10.3 years; number of episodes 2.7 ± 1.9; age of onset 26.7 ± 9.1 years) were recruited from the inpatient department of psychiatry at the University of Zurich. All patients were either medication naïve or not on any psychotropic medication for at least 6 weeks prior to study enrollment. Participants were entered into the study after a full explanation of the purpose of the study and the study procedures and after written consent was obtained as approved by the University of Zurich's institutional review board.
Who may be able to join
- acute depressive episode
Who cannot join
- major medical illness
- history of seizures, head trauma with loss of consciousness
- abnormal clinical laboratory test result, and pregnancy
- atypical forms of depression
- suicidal ideation
- any additional psychiatric disorder
Show all 9Show fewer
- history of substance abuse or dependence
- electroconvulsive therapy in the previous 6 months
- Healthy subjects without any psychiatric, neurologic, or medical illness
About this study
Official title: Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine: A Combined fMRI and MRS Study in Major Depression
The findings may guide future investigations on novel therapeutic targets in depressive subjects. Based on the depicted link between personality traits and altered brain metabolism and function, the latter might be used as supporting objective measures and possible biomarkers for increased depression risk.
Read the detailed description
Interoceptive awareness (IA) is the awareness of bodily signals and has been highlighted as important in many early theories of emotion. William James was one of the first to present a psychological theory linking viscero-afferent feedback to emotional experience. The processing of bodily and thus interoceptive stimuli may be a crucial component in yielding empathy, since affective states are often assumed to involve awareness of one´s own bodily state. The assumption of a close relationship between interceptive awareness and empathy is further supported when considering the regions recruited during both processes, like the insula and the anterior cingulate cortex. Although especially the affective component may implicate interoception and interoceptive awareness, the impact of interoception on empathy has never been evaluated behaviorally or neurophysiologically.
Also associated with altered insula and anterior cingulate cortex (ACC) function is Alexithymia. Alexithymia, a personality trait, is marked by cognitive and affective features including difficulties in identifying and describing feelings as well as in distinguishing feelings from bodily sensations of emotional arousal. Recent studies found a negative correlation between prefrontal glutamate (Glu) and mental perspective taking as well as extraversion. Even though several functional imaging studies investigated the neuronal signatures of interoceptive awareness and the personality trait alexithymia, little is known about the functional relevance of neurotransmitter concentrations
- Conditions
- Depression
- Keywords
- Empathy, Interoceptive Awareness, fMRI, MRS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | 20 patients were enrolled. Subjects were investigated with magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI) and also underwent a psychodiagnostic assessment (evaluating the severity of depression: Hamilton Depression Rating Scale and Beck Depression Inventory; measuring hopelessness: Beck Hopelessness Scale; measuring Alexithymia: Toronto Alexithymia Scale; measuring self-perception: Body Perception Questionnaire). 1-2 days after the imaging patients started the treatment with duloxetine: 30mg for the first three days, then 60-90mg. | |
| healthy controls | Subjects were investigated with magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI) and also underwent a psychodiagnostic assessment (evaluating the severity of depression: Hamilton Depression Rating Scale and Beck Depression Inventory; measuring hopelessness: Beck Hopelessness Scale; measuring Alexithymia: Toronto Alexithymia Scale; measuring self-perception: Body Perception Questionnaire). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain activation patterns after 6 weeks treatment with duloxetine
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinz Boeker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heinz Boeker, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658617
- Sponsor's protocol ID
- PUK09
- Status last verified
- Jan 2016
- First submitted
- 12 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine: A Combined fMRI and MRS Study in Major Depression
- ClinicalTrials.gov ID
- NCT02658617
- Acronym / sponsor ID
- PUK09
- Conditions
- Depression
- Keywords
- Empathy, Interoceptive Awareness, fMRI, MRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heinz BoekerUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Jan 2016 (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.
The findings may guide future investigations on novel therapeutic targets in depressive subjects. Based on the depicted link between personality traits and altered brain metabolism and function, the latter might be used as supporting objective measures and possible biomarkers for increased depression risk.
Detailed description
Interoceptive awareness (IA) is the awareness of bodily signals and has been highlighted as important in many early theories of emotion. William James was one of the first to present a psychological theory linking viscero-afferent feedback to emotional experience. The processing of bodily and thus interoceptive stimuli may be a crucial component in yielding empathy, since affective states are often assumed to involve awareness of one´s own bodily state. The assumption of a close relationship between interceptive awareness and empathy is further supported when considering the regions recruited during both processes, like the insula and the anterior cingulate cortex. Although especially the affective component may implicate interoception and interoceptive awareness, the impact of interoception on empathy has never been evaluated behaviorally or neurophysiologically.
Also associated with altered insula and anterior cingulate cortex (ACC) function is Alexithymia. Alexithymia, a personality trait, is marked by cognitive and affective features including difficulties in identifying and describing feelings as well as in distinguishing feelings from bodily sensations of emotional arousal. Recent studies found a negative correlation between prefrontal glutamate (Glu) and mental perspective taking as well as extraversion. Even though several functional imaging studies investigated the neuronal signatures of interoceptive awareness and the personality trait alexithymia, little is known about the functional relevance of neurotransmitter concentrations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –20 patients were enrolled. Subjects were investigated with magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI) and also underwent a psychodiagnostic assessment (evaluating the severity of depression: Hamilton Depression Rating Scale and Beck Depression Inventory; measuring hopelessness: Beck Hopelessness Scale; measuring Alexithymia: Toronto Alexithymia Scale; measuring self-perception: Body Perception Questionnaire). 1-2 days after the imaging patients started the treatment with duloxetine: 30mg for the first three days, then 60-90mg. |
| healthy controls | – | –Subjects were investigated with magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI) and also underwent a psychodiagnostic assessment (evaluating the severity of depression: Hamilton Depression Rating Scale and Beck Depression Inventory; measuring hopelessness: Beck Hopelessness Scale; measuring Alexithymia: Toronto Alexithymia Scale; measuring self-perception: Body Perception Questionnaire). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with an acute depressive episode (n = 20; 10 females; mean age ± SD age, 32.2 ± 10.3 years; number of episodes 2.7 ± 1.9; age of onset 26.7 ± 9.1 years) were recruited from the inpatient department of psychiatry at the University of Zurich. All patients were either medication naïve or not on any psychotropic medication for at least 6 weeks prior to study enrollment. Participants were entered into the study after a full explanation of the purpose of the study and the study procedures and after written consent was obtained as approved by the University of Zurich's institutional review board.
Key inclusion criteria (1 listed)
- acute depressive episode
Key exclusion criteria (9 listed)
- major medical illness
- history of seizures, head trauma with loss of consciousness
- abnormal clinical laboratory test result, and pregnancy
- atypical forms of depression
- suicidal ideation
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
Changes in brain activation patterns after 6 weeks treatment with duloxetine
Time frame: up to 2 months
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 20 Jan 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Heinz Boeker.
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 1 inclusion and 9 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Changes in brain activation patterns after 6 weeks treatment with duloxetine (time frame: up to 2 months). 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 20 Jan 2016.