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

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT02859103
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.1
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Anhedonia	Drug: Desvenlafaxine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Before and After Treatment With Desvenlafaxine
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Nov 4, 2019
• Actual Study Completion Date: Nov 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Patients in this arm will receive treatment with desvenlafaxine for 8 weeks.	Drug: Desvenlafaxine; Patients will be provided 50mg dose of desvenlafaxine for 1 week titrated up to 100mg dose of desvenlafaxine for 7 weeks.; Other Names: Pristiq
No Intervention: Healthy Control Patients in this arm are healthy controls and will not receive any medication.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Inclusion Criteria

1. DSM-5 criteria for Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis

2. Age between 18 and 60 years

3. Hamilton Depression Rating Scale - 17 item (HRSD-17)58 > 17 (moderate to severe symptoms)

4. Free of psychotropic medications for at least 5 half-lives before baseline visit

5. Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)

Exclusion Criteria

1. Pregnancy/lactation

2. Medical condition requiring immediate investigation or treatment

3. Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)

4. Lifetime history of psychosis, other Axis I comorbidities are allowable

5. Significant Axis II diagnosis

6. Previous intolerance or failure to respond to an adequate trial of desvenlafaxine

7. 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

1. Age between 18 and 60 years

2. Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)

Exclusion Criteria

1. Pregnancy/lactation

2. Medical condition requiring immediate investigation or treatment

3. Lifetime history of any psychiatric disorder

4. Lifetime history of receiving an antidepressant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1M8

Sponsors and Collaborators

• Unity Health Toronto

Investigators

• Principal Investigator: Sakina Rizvi, PhD, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sakina Rizvi, Scientist, Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT02859103
• Other Study ID Numbers: DVS-01
• First Posted: Aug 8, 2016
• Last Update Posted: Nov 2, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Anhedonia; Depressive Disorder; Depressive Disorder, Major; Desvenlafaxine Succinate

Study Results

No Results Posted as of Nov 2, 2020