Neuroimaging Studies of Reward Processing in Depression

NCT ID: NCT03026036

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-03-31

Brief Summary

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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

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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

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Major Depressive Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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MDD

Patients with current Major Depressive Disorder

PET Scan with Raclopride

Intervention Type RADIATION

A subsample (21 per group) will complete the PET imaging.

rMDD

Patients with a history of Major Depressive Disorder

PET Scan with Raclopride

Intervention Type RADIATION

A subsample (21 per group) will complete the PET imaging.

HC

Healthy control participants

PET Scan with Raclopride

Intervention Type RADIATION

A subsample (21 per group) will complete the PET imaging.

Interventions

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PET Scan with Raclopride

A subsample (21 per group) will complete the PET imaging.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* All genders, races, and ethnic origins, aged between 18 and 45
* Capable of providing written informed consent, and fluent in English
* Right-handed
* Absence of any psychotropic medications for at least 2 weeks


* 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)

Exclusion Criteria

* 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)
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Diego Pizzagalli

Professor, Department of Psychiatry, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego A Pizzagalli, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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David Crowley

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P002520

Identifier Type: -

Identifier Source: org_study_id

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