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Characterizing Dopamine Receptor Binding in Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT03537794
Recruitment Status : Not yet recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
Sakina Rizvi, St. Michael's Hospital, Toronto

Brief Summary:
It is estimated that 30% of individuals with Major Depressive Disorder (MDD) fail to respond to conventional antidepressant medication which accounts for over 1 million Canadians in their lifetime. Treatment resistant depression (TRD) patients also have greater psychiatric and medical comorbidity, poorer quality of life and increased suicidal ideation. Yet, there are few treatment strategies available to target TRD and there is a significant lack of evidence about how TRD differs from treatment-responsive depression. This proposal represents the first study to elucidate the neurobiology of TRD with a focus on dopamine receptor function throughout the brain, in order to inform treatment development and clinical characterization of TRD.The ultimate goal of this unique study is to characterize striatal and extrastriatal dopamine D2 and D3 receptor binding potential in patients with TRD, non-resistant MDD and healthy controls. The primary hypothesis is that TRD patients will exhibit greater D2/D3 receptor binding potential compared to non-TRD patients in the following regions of interest: dorsolateral prefrontal cortex, orbitofrontal cortex, and ventral striatum. Secondarily, non-TRD patients will also demonstrate increased binding potential compared to healthy controls in the same brain regions. Whole brain analyses will allow us to take an exploratory approach to other brain regions that may differentiate TRD from non-TRD patients. Participants will be assessed at St. Michael's Hospital (SMH) and the Centre for Addiction and Mental Health (CAMH), which are within a 10 minute driving distance of each other. There will be 3 study visits following written informed consent. Eligibility will be confirmed at a screening visit at SMH where demographic information, including age, sex, education, and medication history will be obtained, as well as the administration of a structured Mini-International Neuropsychiatric Interview (MINI) for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I diagnoses (Sheehan et al, 2015), and an HRSD-17. Within two weeks of the screening visit, participants will undergo a structural magnetic resonance imaging (MRI) scan at SMH prior to the positron-emission tomography (PET) scan at CAMH. The order of the PHNO scans will be counterbalanced.

Condition or disease Intervention/treatment
Treatment Resistant Depression Diagnostic Test: PET scans

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Characterizing Dopamine D2 and D3 Receptor Binding in Treatment Resistant Depression
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment Resistant Depression
Unmedicated Individuals with Treatment Resistant Depression
Diagnostic Test: PET scans
PET scans and PHNO scans

Major Depressive Disorder
Unmedicated Individuals with Major Depressive Disorder
Diagnostic Test: PET scans
PET scans and PHNO scans

Healthy Control
healthy controls with no previous psychiatric disorders
Diagnostic Test: PET scans
PET scans and PHNO scans




Primary Outcome Measures :
  1. Dopamine potential [ Time Frame: 3 years ]
    TRD patients exhibit greater D2/D3 receptor binding potential



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from clinics at St. Michael's Hospital and the Centre for Addiction and Mental Health as well as from research programs at the two sites, which have ongoing MDD clinical trials where patients are required to be unmedicated prior to initiating treatment.
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 55 years
    • Hamilton Depression Rating Scale - 17 item (HRSD-17; Hamilton, 1960) > 14 (moderate to severe symptoms)
    • Free of psychotropic medications for at least 5 half-lives before PET 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 55 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
  • 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

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): NCT03537794


Contacts
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Contact: Sakina Rizvi, PhD 416-864-6060 ext 6489 rizvis@smh.ca
Contact: Ariel Graff-Guerrero, MD, PhD 416-535-850 ext 34834 ariel.graff@camh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Sakina Rizvi, PhD St. Michael's Hospital, Toronto
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Responsible Party: Sakina Rizvi, Dr. Sakina Rizvi, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03537794    
Other Study ID Numbers: TPET-01
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders