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

Unity Health Toronto

Status and phase: Completed; Phase 4

Conditions: Anhedonia; Depression

Treatments: Drug: Desvenlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02859103

DVS-01

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Treatment

Active Comparator group

Description:

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

Treatment:

Drug: Desvenlafaxine

Healthy Control

No Intervention group

Description:

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