Stress Sensitivity and Reward Responsivity in Depression

Depressed Clinical Trial

— CAN-BIND-04  

Official title:

Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798094
• Other study ID #: PSYC-154-14
• Status: Completed
• Start date: July 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressed
• Depression

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Dr. Kate Harkness	Harvard University, McGill University, University Health Network, Toronto, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST)	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	Mood and Anxiety Symptom Questionnaire (MASQ)	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
Secondary	Reward Responsivity: Probabilistic Reward Task	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
Secondary	Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)	Self-report of anhedonia symptoms	Administered at first baseline appointment and covers past 2 weeks prior to interview