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Characterizing Synaptic Density in Treatment Resistant Depression

RecruitingN/A

Sponsor: Unity Health Toronto

Conditions: Treatment Resistant Depression, Depression - Major Depressive Disorder

Interventions: PET scans

Countries: Canada

The purpose of this study is to better understand how certain brain systems work in people with depression, especially in those whose symptoms have not improved with antidepressant treatments. We are particularly interested in synaptic density, which helps us understand how different parts of the brain communicate with each other. Synaptic density levels have implications on overall brain function and cognition. By comparing brain function in people with treatment-resistant depression, people with treatment-responsive depression, and healthy controls, we hope to better understand why some individuals do not respond to antidepressants. This research may help guide the development of more effective treatments in the future.

Eligibility overview

Sex: ALL

Age: 25 Years to 65 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Key inclusion criteria for the MDD patients:

  * DSM-5 criteria for a Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis (Sheehan et al, 2015)
  * Age between 25 and 65 years
  * Hamilton Depression Rating Scale - 17 item (HRSD-17; Hamilton, 1960) \> 14 (moderate to severe symptoms)
  * Free of psychotropic medications (with the exception of SSRIs or SNRIs) for at least 5 half-lives before PET scanning per investigator discretion, after which an insignificant amount of drug is circulating through the body and accessing the brain. This determination will be based on self-report from the participant of when their last dose was. Use of benzodiazepines (except for diazepam) or sedative hypnotics (e.g. zopiclone) is allowable, but the last dose must be at least 72 hours prior to scanning.
  * Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
  * For non-resistant patients: Previous history of response to an antidepressant, in order to increase signal to noise between resistant and non-resistant patients

Key inclusion criteria for the Healthy Controls:

* Ages between 25 and 65 years
* Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)

Exclusion Criteria:

Key exclusion criteria for the MDD patients:

* Pregnancy/lactation
* Medical condition requiring immediate investigation or treatment
* Recent (\< 6 months)/current history of drug abuse/dependence
* Lifetime history of psychosis, other Axis I comorbidities are allowable
* Use of any psychotropic use within 5 half-lives before the PET scanning, with the exception of SSRIs and SNRIs
* For non-resistant patients: Failure of \> 2 antidepressant treatments of adequate dose and duration for current MDE.

Key exclusion criteria for the Healthy Controls:

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

Locations (1)

Toronto, Ontario, Canada