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Completed

NCT Number: NCT02859103

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

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.

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Key information

Conditions

Depression Anhedonia Behavior Behavioral Symptoms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desvenlafaxine

Drug

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

Other names: Pristiq

Primary outcomes

  1. Measuring Reward association and valuation using the Reward Association Task

    Time frame: Change from Baseline at 8 Weeks

    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

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

    Time frame: Change from Baseline at 8 Weeks

    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

  3. Anticipation of reward using the monetary incentive delay during fMRI

    Time frame: Change from Baseline at 8 Weeks

    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

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

    Time frame: Change from Baseline at 8 Weeks

    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

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

    Time frame: Change from Baseline at 8 Weeks

    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

  6. Feedback integration using the Probabilistic Reversal Learning task during fMRI

    Time frame: Change from Baseline at 8 Weeks

    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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2016
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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