Clinical trial NCT02798094: Stress Sensitivity and Reward Responsivity in Depression
Official title: Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressed
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: University of Calgary
name: Harvard University
name: McGill University
First posted: 2016-06-14
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.

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.

Eligibility 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

Primary outcomes:
measure: Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST)
timeFrame: 2 hours after beginning of Time B Appointment
Secondary outcomes:
measure: Mood and Anxiety Symptom Questionnaire (MASQ)
timeFrame: Administered at first baseline appointment and covers past 2 weeks
measure: Reward Responsivity: Probabilistic Reward Task
timeFrame: Administered at second baseline appointment
measure: Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)
timeFrame: Administered at first baseline appointment and covers past 2 weeks prior to interview
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queens University
name: Kate Harkness, PhD
role: PRINCIPAL_INVESTIGATOR
References: