DepressedCAN-BIND-04NCT02798094
Stress Sensitivity and Reward Responsivity in Depression
An observational study of Depressed, run by Dr. Kate Harkness at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressed
- How many people
- 219 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Outpatients aged 18-65
- Currently suffering from unipolar depression
- Fluency in English, sufficient to complete the interviews and self-report questionnaires
- 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
Who cannot join
- 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
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- High suicidal risk, defined by clinician judgement
- For Healthy Control Participants:
- History of neurological insult (e.g., concussion), neurological disease, seizure disorder
- Smokers
- Pregnant women
- Endocrine disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major 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.
Read the 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.
- Conditions
- Depressed
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depressed Participants | No intervention | |
| Healthy Control Participants | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after beginning of Time B Appointment
Secondary outcomes (3)
Mood and Anxiety Symptom Questionnaire (MASQ)
Self-report scale of general distress (GD), anhedonic depression (AD), and anxious arousal (AA) symptoms
Measured: Administered at first baseline appointment and covers past 2 weeks
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.
Measured: Administered at second baseline appointment
Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)
Self-report of anhedonia symptoms
Measured: Administered at first baseline appointment and covers past 2 weeks prior to interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJul 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Kate Harkness
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, University of Calgary, Harvard University, McGill University
- Responsible party
- Sponsor-investigator, Dr. Kate Harkness, Queen's University
- Investigators
- Kate Harkness, PhD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798094
- Sponsor's protocol ID
- PSYC-154-14
- Acronym
- CAN-BIND-04
- Status last verified
- Aug 2019
- First submitted
- 13 May 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression
- ClinicalTrials.gov ID
- NCT02798094
- Acronym / sponsor ID
- CAN-BIND-04 / PSYC-154-14
- Conditions
- Depressed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Dr. Kate HarknessUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, University of Calgary, Harvard University, McGill University
- Study start
- Jul 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed Participants | – | –No intervention |
| Healthy Control Participants | – | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (7 listed)
- Outpatients aged 18-65
- Currently suffering from unipolar depression
- Fluency in English, sufficient to complete the interviews and self-report questionnaires
- Adults aged 18-65
- No history of Axis I disorders according to DSM-IV-TR criteria, as determined by the SCID
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Mood and Anxiety Symptom Questionnaire (MASQ)
Time frame: Administered at first baseline appointment and covers past 2 weeks
Reward Responsivity: Probabilistic Reward Task
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Harkness, PhD principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressed, run by Dr. Kate Harkness at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST) (time frame: 2 hours after beginning of Time B Appointment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.