- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02798094
Stress Sensitivity and Reward Responsivity in Depression (CAN-BIND-04)
Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- Queen's University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Depressed Participants
No intervention
|
Healthy Control Participants
No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 hours after beginning of Time B Appointment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Administered at first baseline appointment and covers past 2 weeks
|
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.
|
Administered at second baseline appointment
|
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
|
Administered at first baseline appointment and covers past 2 weeks prior to interview
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate Harkness, PhD, Queens University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYC-154-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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