Neuroimaging Studies of Reward Processing in Depression

NCT03026036 | Completed

• 1 other identifier: 2015P002520
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Depression; MRI; PET; Reward

Outcome Measures

Primary Outcomes (7)

• Behavioral Performance on the Probabilistic Stimulus Selection Task

  The Probablilistic Reward Task operationalizes positive reinforcement learning

  Screening visit (Day 0)

• MRI Data

  MRI scans for a total of 90 minutes take place within 30 days of Screening Visit

• PET scan with raclopride

  a total of 90 minutes take place after the MRI data collection

• Salivary Cortisol

  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)

  During the MRI visit (on or before Day 30)

• Follow-up Clinical Interviews

  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.

  Administered during MRI scan (on or before Day 30)

Study Arms (3)

MDD

Patients with current Major Depressive Disorder

Radiation: PET Scan with Raclopride

rMDD

Patients with a history of Major Depressive Disorder

Radiation: PET Scan with Raclopride

HC

Healthy control participants

Radiation: PET Scan with Raclopride

Interventions

PET Scan with Raclopride RADIATION

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

HC; MDD; rMDD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Current Major Depressive Disorder (MDD), or Remitted Major Depressive Disorder (rMDD)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

David Crowley

Belmont, Massachusetts, 02478, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, saliva samples

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Magnetic Resonance Spectroscopy; Raclopride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Diego A Pizzagalli, Ph.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 20, 2017
• Study Start: April 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: All collected IPD are shared every 6 months (1/15 and 7/15 of each year)
• Access Criteria: Investigators may request for access for approval by the NIMH.

Locations

US (1)