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Completed

NCT Number: NCT02798094

Stress Sensitivity and Reward Responsivity in Depression

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.

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Key information

Conditions

Depressed Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr. Kate Harkness

Other

Collaborators

  • Harvard University
  • McGill University
  • University Health Network, Toronto
  • University of Calgary

Registry information

Official study title

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

Acronym: CAN-BIND-04

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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