Major Depressive DisorderNCT03026036
Neuroimaging Studies of Reward Processing in Depression
An observational study of Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
This study investigates stress-related signaling of glutamate and dopamine within the reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to predict depressive symptoms in the future. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- PET Scan with Raclopride
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Current Major Depressive Disorder (MDD), or Remitted Major Depressive Disorder (rMDD)
Who may be able to join
- Current DSM-5 diagnostic criteria for MDD (as diagnosed with the use of the SCID)
- History of at least one major depressive episode within the past five years
- Not currently depressed
- Absence of any medical, neurological, and psychiatric illness (including alcohol/substance abuse)
Who cannot join
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
- Pregnant women
- Failure to meet standard MRI or PET safety requirements
- Serious or unstable medical illness
- History of seizure disorder
- History or current diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, OCD, PTSD, mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion)
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- Simple phobia, social anxiety disorder, and generalized anxiety disorder will be allowed only if secondary to MDD and only in the MDD group
- History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
- History of use of dopaminergic drugs (including methylphenidate)
- Patients with a lifetime history of electroconvulsive therapy (ECT)
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates stress-related signaling of glutamate and dopamine within the reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to predict depressive symptoms in the future. This will be achieved through various neuroimaging tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.
Read the detailed description
The overarching goals of this research are to investigate: (1) stress-induced glutamatergic abnormalities and their relation to disruption within the corticostriatal valuation circuit in MDD; (2) stress-induced DA signaling disruptions in MDD; and (3) the predictive validity of these two pathophysiological mechanisms. This will be achieved through an innovative integration of (1) proton magnetic resonance spectroscopy (MRS)-based assessments of glutamatergic metabolites in the mPFC; (2) functional magnetic resonance imaging (fMRI) probes of the corticostriatal valuation circuit with well-established stress manipulations (MAST) and assessments (cortisol and inflammatory markers); (3) positron emission tomography (PET)-based measurement of striatal DA release with well-established stress manipulations and assessments (cortisol and inflammatory markers); and (4) a naturalistic follow-up design.
- Conditions
- Major Depressive Disorder
- Being tested
- PET Scan with Raclopride
- Keywords
- Depression, MRI, PET, Reward
- 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.
PET Scan with RacloprideRadiation
A subsample (21 per group) will complete the PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| MDD | Patients with current Major Depressive Disorder Receives: Radiation: PET Scan with Raclopride | |
| rMDD | Patients with a history of Major Depressive Disorder Receives: Radiation: PET Scan with Raclopride | |
| HC | Healthy control participants Receives: Radiation: PET Scan with Raclopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Performance on the Probabilistic Stimulus Selection Task
The Probablilistic Reward Task operationalizes positive reinforcement learning
Measured: Screening visit (Day 0)
MRI Data
Measured: MRI scans for a total of 90 minutes take place within 30 days of Screening Visit
PET scan with raclopride
Measured: a total of 90 minutes take place after the MRI data collection
Salivary Cortisol
Measured: 6 times during MRI visit (on or before Day 30), and 4 times during PET visit (on or before Day 30)
Four Blood Samples (6ml)
Measured: During the MRI visit (on or before Day 30)
Follow-up Clinical Interviews
Measured: 6 months and 12 months after the MRI scanning visit
Behavioral Performance on the Instrumental Learning Task
The instrumental learning task is designed to measure participant learning from reward and punishment.
Measured: Administered during MRI scan (on or before Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionMar 2021
- Study completionMar 2021
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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Pizzagalli, Mclean Hospital
- Investigators
- Diego A Pizzagalli, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026036
- Sponsor's protocol ID
- 2015P002520
- Status last verified
- Feb 2023
- First submitted
- 27 Dec 2016
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All collected IPD will be shared via NIMH Data Archive (as part of data submission agreement)
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Studies of Reward Processing in Depression
- ClinicalTrials.gov ID
- NCT03026036
- Acronym / sponsor ID
- 2015P002520
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, MRI, PET, Reward
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 20 Jan 2017 (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 investigates stress-related signaling of glutamate and dopamine within the reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to predict depressive symptoms in the future. This will be achieved through various neuroimaging tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.
Detailed description
The overarching goals of this research are to investigate: (1) stress-induced glutamatergic abnormalities and their relation to disruption within the corticostriatal valuation circuit in MDD; (2) stress-induced DA signaling disruptions in MDD; and (3) the predictive validity of these two pathophysiological mechanisms. This will be achieved through an innovative integration of (1) proton magnetic resonance spectroscopy (MRS)-based assessments of glutamatergic metabolites in the mPFC; (2) functional magnetic resonance imaging (fMRI) probes of the corticostriatal valuation circuit with well-established stress manipulations (MAST) and assessments (cortisol and inflammatory markers); (3) positron emission tomography (PET)-based measurement of striatal DA release with well-established stress manipulations and assessments (cortisol and inflammatory markers); and (4) a naturalistic follow-up design.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDD | – | Radiation: PET Scan with RaclopridePatients with current Major Depressive Disorder |
| rMDD | – | Radiation: PET Scan with RaclopridePatients with a history of Major Depressive Disorder |
| HC | – | Radiation: PET Scan with RacloprideHealthy control participants |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Current Major Depressive Disorder (MDD), or Remitted Major Depressive Disorder (rMDD)
Key inclusion criteria (4 listed)
- Current DSM-5 diagnostic criteria for MDD (as diagnosed with the use of the SCID)
- History of at least one major depressive episode within the past five years
- Not currently depressed
- Absence of any medical, neurological, and psychiatric illness (including alcohol/substance abuse)
Key exclusion criteria (10 listed)
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
- Pregnant women
- Failure to meet standard MRI or PET safety requirements
- Serious or unstable medical illness
- History of seizure disorder
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 |
|---|---|---|
| PET Scan with RacloprideA subsample (21 per group) will complete the PET imaging. | Radiation | HC, MDD, rMDD |
Primary outcome
Behavioral Performance on the Probabilistic Stimulus Selection Task
Time frame: Screening visit (Day 0)
The Probablilistic Reward Task operationalizes positive reinforcement learning
MRI Data
Time frame: MRI scans for a total of 90 minutes take place within 30 days of Screening Visit
PET scan with raclopride
Time frame: a total of 90 minutes take place after the MRI data collection
Salivary Cortisol
Time frame: 6 times during MRI visit (on or before Day 30), and 4 times during PET visit (on or before Day 30)
Four Blood Samples (6ml)
Time frame: During the MRI visit (on or before Day 30)
Follow-up Clinical Interviews
Time frame: 6 months and 12 months after the MRI scanning visit
Behavioral Performance on the Instrumental Learning Task
Time frame: Administered during MRI scan (on or before Day 30)
The instrumental learning task is designed to measure participant learning from reward and punishment.
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 3 Feb 2023.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared via NIMH Data Archive (as part of data submission agreement)
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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.
Diego A Pizzagalli, Ph.D. principal investigator
Mclean Hospital
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 Mclean Hospital 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 4 inclusion and 10 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 3 Feb 2023. 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.
What does the primary outcome measure?
Behavioral Performance on the Probabilistic Stimulus Selection Task (time frame: Screening visit (Day 0)). The study lists 7 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 3 Feb 2023.