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Trial record 9 of 89 for:    DESVENLAFAXINE

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

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ClinicalTrials.gov Identifier: NCT02859103
Recruitment Status : Unknown
Verified October 2017 by Sakina Rizvi, St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : August 8, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sakina Rizvi, St. Michael's Hospital, Toronto

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : June 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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 Name: Pristiq

No Intervention: Healthy Control
Patients in this arm are healthy controls and will not receive any medication.



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859103


Contacts
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Contact: Troy Chow, HBSc 416-864-6060 ext 7844 chowt@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1M8
Contact: Troy Chow, HBSc    416-864-6060 ext 7844    chowt@smh.ca   
Principal Investigator: Sakina Rizvi, PhD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Sakina Rizvi, PhD St. Michael's Hospital, Toronto

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Responsible Party: Sakina Rizvi, Scientist, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02859103     History of Changes
Other Study ID Numbers: DVS-01
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Desvenlafaxine Succinate
Anhedonia
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs