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

• ClinicalTrials.gov Identifier: NCT02798094
• Recruitment Status: Completed
• First Posted: June 14, 2016
• Last Update Posted: August 28, 2019
• Sponsor: Dr. Kate Harkness
• Collaborators: University Health Network, Toronto; University of Calgary; Harvard University; McGill University
• Information provided by (Responsible Party): Dr. Kate Harkness, Queen's University

Study Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 219 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
• Actual Primary Completion Date: December 31, 2018
• Actual Study Completion Date: December 31, 2018

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Canada, Ontario

Queen's University

Kingston, Ontario, Canada, K7L 3N6

Sponsors and Collaborators

Dr. Kate Harkness

University Health Network, Toronto

University of Calgary

Harvard University

McGill University

Investigators

• Principal Investigator: Kate Harkness, PhD; Queens University

More Information

• Responsible Party: Dr. Kate Harkness, Dr., Queen's University
• ClinicalTrials.gov Identifier: NCT02798094
• Other Study ID Numbers: PSYC-154-14
• First Posted: June 14, 2016
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Depression; Behavioral Symptoms