Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress Sensitivity and Reward Responsivity in Depression (CAN-BIND-04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02798094
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
University Health Network, Toronto
University of Calgary
Harvard University
McGill University
Information provided by (Responsible Party):
Dr. Kate Harkness, Queen's University

Brief Summary:
The goal of this project is to learn more about the different ways in which people process information that is stressful and rewarding, and how abnormalities in these two processes are related to depression.

Condition or disease
Depressed

Detailed Description:

Participants will participate in two 3-hour sessions separated by a week at Providence Care, Mental Health Services, and a third, 1.5-hour session at the Queen's MRI Facility. At the first session participants will complete a packet of questionnaires about their mood and take part in an interview about their mood, medications, drug use, and any other symptoms, as well as an interview about their relationships with their parents and any experiences of abuse. At the second session participants will participate in a stress test, which involves giving a speech to a panel. The investigators will also collect saliva samples to look at stress hormones. Participants will also complete a task on the computer that involves looking at cartoon faces and making decisions about them. At the third session, the investigators take images of of participant's brain using a magnetic resonance scanner.

Participants are invited to participate in a 6-month follow-up for this study, which would involve the same procedure as outline above.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression
Actual Study Start Date : July 2015
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort
Depressed Participants
No intervention
Healthy Control Participants
No intervention



Primary Outcome Measures :
  1. Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST) [ Time Frame: 2 hours after beginning of Time B Appointment ]
    Participants are required to give a speech and an arithmetic test in front of a panel. Saliva samples are collected at 8 points throughout the test.


Secondary Outcome Measures :
  1. Mood and Anxiety Symptom Questionnaire (MASQ) [ Time Frame: Administered at first baseline appointment and covers past 2 weeks ]
    Self-report scale of general distress (GD), anhedonic depression (AD), and anxious arousal (AA) symptoms

  2. Reward Responsivity: Probabilistic Reward Task [ Time Frame: Administered at second baseline appointment ]
    Computerized task that requires participants to choose between two stimuli and develop a response bias to the more frequently rewarded stimulus.

  3. Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C) [ Time Frame: Administered at first baseline appointment and covers past 2 weeks prior to interview ]
    Self-report of anhedonia symptoms


Biospecimen Retention:   Samples Without DNA
Saliva is collected at eight points across the second session in 5mL vials. Saliva samples are assayed for neuroendocrine hormones (e.g., cortisol). Whole blood is collected in EDTA tubes at the first session. Whole blood is currently being banked. No assays are being conducted at this time.


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

For Depressed Participants:

Inclusion Criteria:

  • Outpatients aged 18-65
  • Currently suffering from unipolar depression
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

  • Clinical diagnosis of bipolar disorder, psychotic disorders, current alcohol/substance dependence, or significant medical comorbidity
  • Treatment-resistant (defined as failing more than 3 trials of anti-depressant medication)
  • History of neurological insult (e.g., concussion), neurological disease, seizure disorder
  • Smokers
  • Pregnant women
  • Endocrine disorders
  • High suicidal risk, defined by clinician judgement

For Healthy Control Participants:

Inclusion Criteria:

  • Adults aged 18-65
  • No history of Axis I disorders according to DSM-IV-TR criteria, as determined by the SCID
  • No first-degree relatives diagnosed with bipolar disorder
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

  • History of neurological insult (e.g., concussion), neurological disease, seizure disorder
  • Smokers
  • Pregnant women
  • Endocrine disorders

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): NCT02798094


Contacts
Layout table for location contacts
Contact: Raymond MacNeil, BAH 613-533-6003 sara.canbind4@gmail.com

Locations
Layout table for location information
Canada, Ontario
Queen's University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Raymond MacNeil, BAH    613-533-6003    rm165@queensu.ca   
Principal Investigator: Kate Harkness, PhD         
Sub-Investigator: Roumen Milev, MD         
Sponsors and Collaborators
Dr. Kate Harkness
University Health Network, Toronto
University of Calgary
Harvard University
McGill University
Investigators
Layout table for investigator information
Principal Investigator: Kate Harkness, PhD Queens University

Layout table for additonal information
Responsible Party: Dr. Kate Harkness, Dr., Queen's University
ClinicalTrials.gov Identifier: NCT02798094     History of Changes
Other Study ID Numbers: PSYC-154-14
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms