Stress Sensitivity and Reward Responsivity in Depression | NCT02798094

Studies
Stress Sensitivity and Reward Responsivity in Depression

NCT02798094

Sponsor

Dr. Kate Harkness

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

219Actual

Phase

Not provided

Conditions

Depressed

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

May 13, 2016

First Submission Date that Met QC Criteria

Jun 13, 2016

First Posted Date

Jun 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Name	Class
University Health Network, Toronto	OTHER
University of Calgary	OTHER
Harvard University	OTHER
McGill University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

219Actual

Label	Type	Description	Intervention Names
Depressed Participants		No intervention
Healthy Control Participants		No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Reward Responsivity: Probabilistic Reward Task

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Kate Harkness, PhD	Queens University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Queen's University		Kingston	Ontario	K7L 3N6	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003244	Consciousness Disorders

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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