NCT02798094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.5 years

First QC Date

May 13, 2016

Last Update Submit

August 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Mood and Anxiety Symptom Questionnaire (MASQ)

    Administered at first baseline appointment and covers past 2 weeks

  • Reward Responsivity: Probabilistic Reward Task

    Administered at second baseline appointment

  • Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)

    Administered at first baseline appointment and covers past 2 weeks prior to interview

Study Arms (2)

Depressed Participants

No intervention

Healthy Control Participants

No intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Outpatients aged 18-65
  • Currently suffering from unipolar depression
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

You may not qualify if:

  • 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:
  • 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
  • History of neurological insult (e.g., concussion), neurological disease, seizure disorder
  • Smokers
  • Pregnant women
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva is collected at eight points across the second session in 5mL vials. Saliva samples are assayed for neuroendocrine hormones (e.g., cortisol). Whole blood is collected in EDTA tubes at the first session. Whole blood is currently being banked. No assays are being conducted at this time.

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Kate Harkness, PhD

    Queens University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 13, 2016

First Posted

June 14, 2016

Study Start

July 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations