Neuroimaging Studies of Reward Processing in Depression

Major Depressive Disorder Clinical Trial

Official title:

Neuroimaging Studies of Reward Processing in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026036
• Other study ID #: 2015P002520
• Status: Completed
• Start date: April 2016
• Est. completion date: March 2021

Study information

• Verified date: February 2023
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This will be achieved through various neuroimaging tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

General 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

Inclusion Criteria for Current Depression Group (MDD):

• Current DSM-5 diagnostic criteria for MDD (as diagnosed with the use of the SCID)

Inclusion Criteria for Remitted Depression Group (rMDD):

• History of at least one major depressive episode within the past five years

• Not currently depressed

Inclusion Criteria for Healthy Control Group (HC):

• 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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Radiation:
• PET Scan with Raclopride
A subsample (21 per group) will complete the PET imaging.

Locations

Country	Name	City	State
United States	David Crowley	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Performance on the Probabilistic Stimulus Selection Task	The Probablilistic Reward Task operationalizes positive reinforcement learning	Screening visit (Day 0)
Primary	MRI Data		MRI scans for a total of 90 minutes take place within 30 days of Screening Visit
Primary	PET scan with raclopride		a total of 90 minutes take place after the MRI data collection
Primary	Salivary Cortisol		6 times during MRI visit (on or before Day 30), and 4 times during PET visit (on or before Day 30)
Primary	Four Blood Samples (6ml)		During the MRI visit (on or before Day 30)
Primary	Follow-up Clinical Interviews		6 months and 12 months after the MRI scanning visit
Primary	Behavioral Performance on the Instrumental Learning Task	The instrumental learning task is designed to measure participant learning from reward and punishment.	Administered during MRI scan (on or before Day 30)