Major Depressive DisorderNCT01465165
Use of Multiple Brain Imaging Modalities (PET and MRS) to Identify Metabolic Abnormalities in Major Depression
An observational study of Major Depressive Disorder, run by Paul Carlson at 1 site in United States.
Trial summary
Several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. The current study utilizes two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission tomography (PET) and multinuclear… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2011to 24 Jun 2012
- 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
Study population: Community sample
Who may be able to join
- Meet DSM-IV criteria for Major Depressive Disorder (MDD), Recurrent
- Montgomery-Asberg Depression Rating Scale (MADRS) score > 18
Who cannot join
- Any coexisting psychiatric illness other than generalized anxiety disorder, panic disorder, or social/specific phobias
- Any history of substance dependence
- Substance abuse within the past 6 months
- Significant risk of suicide, as defined by score >4 on item 10 of the MADRS or in the clinical judgment of the study physician
- Any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of MRS or PET imaging
- For the subset of unmedicated MDD patients, any psychotropic medications within 4 weeks prior to scanning. For the subgroup of medicated patients, they may be taking a stable dose (i.e., same dose for at least 4 weeks at the time of scanning) of standard antidepressant medications, but may not be taking any other psychotropic medication.
- Inability to give informed consent
- Contraindication to MRI (e.g., pacemaker, ferromagnetic implants in the body)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Dept of Psychiatry
Salt Lake City, Utah, 84112
About this study
Official title: Comparison of Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Magnetic Resonance Spectroscopy (MRS) as Bioenergetic Imaging Modalities in Healthy Human Brain and Major Depressive Disorder
Several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. The current study utilizes two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission tomography (PET) and multinuclear magnetic resonance spectroscopy (MRS), to better understand the nature of these metabolic abnormalities in major depressive disorder (MDD). The investigators hypothesize that individuals with depression will have increased metabolic activity as measured by PET in certain brain regions involved in mood regulation, but that this metabolic activity will be inefficient based on MRS findings. For this study, the investigators will study 10 medication-free, currently depressed participants with recurrent MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication, and up to 20 healthy control participants matched to depressed participants for age and gender. Depressed and healthy participants will each undergo one PET scan and one MRS scanning session.
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Positron emission tomography, Magnetic resonance spectroscopy, glucose metabolism, ATP, phosphocreatine
- Medical subject headings
- Depressive Disorder, Major, 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 |
|---|---|---|
| Depressed, unmedicated | Participants with MDD who are not treated with any antidepressant medication | |
| Depressed, on antidepressant | Participants with MDD, currently depressed but on a stable dose of an SSRI antidepressant | |
| Healthy control | Healthy participant with no MDD or other psychiatric condition, matched by age and gender to MDD participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
high energy phosphate metabolites (Phosphocreatine (PCr)) as measured by magnetic resonance spectroscopy
relative concentration of Pcr
Measured: cross-sectional
Secondary outcomes (3)
regional cerebral glucose metabolism, as measured by Positron Emission Tomography (PET)
binding potential of FDG
Measured: cross-sectional
N-Acetyl-Aspartate (NAA) metabolite intensity, as measured by proton Magnetic Resonance Spectroscopy (MRS)
relative concentration of NAA
Measured: cross-sectional
severity of depressive symptoms, as scored on the Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS composite score
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study start15 May 2011
- Primary completion24 Jun 2012
- Study completion24 Jun 2012
Why it stopped: Study procedures were not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Carlson
- Sponsor type
- University, hospital or other
- Collaborators
- Western Institute for Biomedical Research, University of Utah, Huntsman Cancer Institute
- Responsible party
- Sponsor-investigator, Paul Carlson, University of Utah
- Investigators
- Paul J Carlson, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465165
- Sponsor's protocol ID
- WIBR08-PJC
- Status last verified
- May 2017
- First submitted
- 1 Nov 2011
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified scanning images may be individually examined after the study is completed if new analysis methods become available to collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Magnetic Resonance Spectroscopy (MRS) as Bioenergetic Imaging Modalities in Healthy Human Brain and Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01465165
- Acronym / sponsor ID
- WIBR08-PJC
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Positron emission tomography, Magnetic resonance spectroscopy, glucose metabolism, ATP, phosphocreatine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study procedures were not feasible.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Paul CarlsonUniversity, hospital or other
- Collaborators
- Western Institute for Biomedical Research, University of Utah, Huntsman Cancer Institute
- Study start
- 15 May 2011 (actual)
- Primary completion
- 24 Jun 2012 (actual)
- Study completion
- 24 Jun 2012 (actual)
- First posted
- 4 Nov 2011 (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.
Several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. The current study utilizes two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission tomography (PET) and multinuclear magnetic resonance spectroscopy (MRS), to better understand the nature of these metabolic abnormalities in major depressive disorder (MDD). The investigators hypothesize that individuals with depression will have increased metabolic activity as measured by PET in certain brain regions involved in mood regulation, but that this metabolic activity will be inefficient based on MRS findings. For this study, the investigators will study 10 medication-free, currently depressed participants with recurrent MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication, and up to 20 healthy control participants matched to depressed participants for age and gender. Depressed and healthy participants will each undergo one PET scan and one MRS scanning session.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depressed, unmedicated | – | –Participants with MDD who are not treated with any antidepressant medication |
| Depressed, on antidepressant | – | –Participants with MDD, currently depressed but on a stable dose of an SSRI antidepressant |
| Healthy control | – | –Healthy participant with no MDD or other psychiatric condition, matched by age and gender to MDD participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Meet DSM-IV criteria for Major Depressive Disorder (MDD), Recurrent
- Montgomery-Asberg Depression Rating Scale (MADRS) score > 18
Key exclusion criteria (8 listed)
- Any coexisting psychiatric illness other than generalized anxiety disorder, panic disorder, or social/specific phobias
- Any history of substance dependence
- Substance abuse within the past 6 months
- Significant risk of suicide, as defined by score >4 on item 10 of the MADRS or in the clinical judgment of the study physician
- Any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of MRS or PET imaging
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
high energy phosphate metabolites (Phosphocreatine (PCr)) as measured by magnetic resonance spectroscopy
Time frame: cross-sectional
relative concentration of Pcr
3 secondary outcomes
regional cerebral glucose metabolism, as measured by Positron Emission Tomography (PET)
Time frame: cross-sectional
N-Acetyl-Aspartate (NAA) metabolite intensity, as measured by proton Magnetic Resonance Spectroscopy (MRS)
Time frame: cross-sectional
severity of depressive symptoms, as scored on the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: cross-sectional
Results and safety
The study was stopped early (reason given: Study procedures were not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: Yes. De-identified scanning images may be individually examined after the study is completed if new analysis methods become available to collaborators.
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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.
Paul J Carlson, M.D. principal investigator
University of Utah
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 Major Depressive Disorder, run by Paul Carlson 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 19 May 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 was stopped early (reason given: Study procedures were not feasible.). Results are not available in the source record.
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?
high energy phosphate metabolites (Phosphocreatine (PCr)) as measured by magnetic resonance spectroscopy (time frame: cross-sectional). 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 19 May 2017.