Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Desvenlafaxine

About this trial

This is an interventional other trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion/exclusion criteria for MDD patients (n=40) are as follows:

Inclusion Criteria

DSM-5 criteria for Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis
Age between 18 and 60 years
Hamilton Depression Rating Scale - 17 item (HRSD-17)58 > 17 (moderate to severe symptoms)
Free of psychotropic medications for at least 5 half-lives before baseline visit
Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)

Exclusion Criteria

Pregnancy/lactation
Medical condition requiring immediate investigation or treatment
Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
Lifetime history of psychosis, other Axis I comorbidities are allowable
Significant Axis II diagnosis
Previous intolerance or failure to respond to an adequate trial of desvenlafaxine
Failure of > 2 antidepressant treatments of adequate dose and duration for current MDE

Inclusion/exclusion criteria for Healthy Controls (n=20) are as follows:

Inclusion Criteria

Age between 18 and 60 years
Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)

Exclusion Criteria

Pregnancy/lactation
Medical condition requiring immediate investigation or treatment
Lifetime history of any psychiatric disorder
Lifetime history of receiving an antidepressant

Sites / Locations

St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

Healthy Control

Arm Description

Patients in this arm will receive treatment with desvenlafaxine for 8 weeks.

Patients in this arm are healthy controls and will not receive any medication.

Outcomes

Primary Outcome Measures

Measuring Reward association and valuation using the Reward Association Task

Based on signal detection theory, it evaluates response bias as a function of prior reward and permits an objective assessment of disorder-related sensitivity to reward. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways

Measuring Expectation using a prediction error task, to measure learning and choosing, during functional Magnetic Resonance Imaging (fMRI)

This distinction was included in the design in order to dissociate potentially different neural circuits subserving learning reward associations and using them to guide behavior. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways

Anticipation of reward using the monetary incentive delay during fMRI

This task was designed to disentangle anticipatory vs. consummatory phases of reward processing. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways

Motivation/effort using the Cued-Reinforcement Reaction Time Task and the EEfRT task.

The Cued-Reinforcement Reaction Time Task (CRRT) provides an evaluation of reward-based reaction time speed as an index of incentive motivation.The EEfRT task allows analysis of the predictive value of reward probability and magnitude on effort-based decision making. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways

Pleasure/Liking using the monetary incentive delay task in an fMRI

This task was designed to disentangle anticipatory vs. consummatory phases of reward processing. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways

Feedback integration using the Probabilistic Reversal Learning task during fMRI

participants are presented with a choice of two stimuli. Based on their first choice, the selected stimulus will be rewarded with a high probability, while the other will be rewarded with a low probability.To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways

Secondary Outcome Measures

Full Information

NCT ID

NCT02859103

First Posted

July 15, 2016

Last Updated

October 28, 2020

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02859103

Brief Title

Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment

Official Title

A Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Before and After Treatment With Desvenlafaxine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

November 4, 2019 (Actual)

Study Completion Date

November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major depressive disorder (MDD), and it may impact how patients with depression experience reward. Understanding how anhedonia is related to the experience of reward may help improve how depression is treated. Computer tasks can be used to measure how reward is experienced, and these measures might be able to predict things like who is likely to become depressed, or who will respond to antidepressant medication. Studying the relationship between anhedonia and reward in patients with depression might also tell us something about how to improve diagnosis and treatment of other psychiatric disorders.This is an open label controlled treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas that may be related to how people perform on the tasks. The investigators goal is to use this information to help us find a reliable predictor that can be used to guide MDD treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anhedonia

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

Patients in this arm will receive treatment with desvenlafaxine for 8 weeks.

Arm Title

Healthy Control

Arm Type

No Intervention

Arm Description

Patients in this arm are healthy controls and will not receive any medication.

Intervention Type

Drug

Intervention Name(s)

Desvenlafaxine

Other Intervention Name(s)

Pristiq

Intervention Description

Patients will be provided 50mg dose of desvenlafaxine for 1 week titrated up to 100mg dose of desvenlafaxine for 7 weeks.

Primary Outcome Measure Information:

Title

Measuring Reward association and valuation using the Reward Association Task

Description

Based on signal detection theory, it evaluates response bias as a function of prior reward and permits an objective assessment of disorder-related sensitivity to reward. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways

Time Frame