Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT02798094
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Sensitivity and Reward Responsivity in Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2016-05-13', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST)', 'timeFrame': '2 hours after beginning of Time B Appointment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mood and Anxiety Symptom Questionnaire (MASQ)', 'timeFrame': 'Administered at first baseline appointment and covers past 2 weeks', 'description': 'Self-report scale of general distress (GD), anhedonic depression (AD), and anxious arousal (AA) symptoms'}, {'measure': 'Reward Responsivity: Probabilistic Reward Task', 'timeFrame': 'Administered at second baseline appointment', 'description': 'Computerized task that requires participants to choose between two stimuli and develop a response bias to the more frequently rewarded stimulus.'}, {'measure': 'Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)', 'timeFrame': 'Administered at first baseline appointment and covers past 2 weeks prior to interview', 'description': 'Self-report of anhedonia symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depressed']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants are invited to participate in a 6-month follow-up for this study, which would involve the same procedure as outline above."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'For Depressed Participants:\n\nInclusion Criteria:\n\n* Outpatients aged 18-65\n* Currently suffering from unipolar depression\n* Fluency in English, sufficient to complete the interviews and self-report questionnaires\n\nExclusion Criteria:\n\n* Clinical diagnosis of bipolar disorder, psychotic disorders, current alcohol/substance dependence, or significant medical comorbidity\n* Treatment-resistant (defined as failing more than 3 trials of anti-depressant medication)\n* History of neurological insult (e.g., concussion), neurological disease, seizure disorder\n* Smokers\n* Pregnant women\n* Endocrine disorders\n* High suicidal risk, defined by clinician judgement\n\nFor Healthy Control Participants:\n\nInclusion Criteria:\n\n* Adults aged 18-65\n* No history of Axis I disorders according to DSM-IV-TR criteria, as determined by the SCID\n* No first-degree relatives diagnosed with bipolar disorder\n* Fluency in English, sufficient to complete the interviews and self-report questionnaires\n\nExclusion Criteria:\n\n* History of neurological insult (e.g., concussion), neurological disease, seizure disorder\n* Smokers\n* Pregnant women\n* Endocrine disorders'}, 'identificationModule': {'nctId': 'NCT02798094', 'acronym': 'CAN-BIND-04', 'briefTitle': 'Stress Sensitivity and Reward Responsivity in Depression', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression', 'orgStudyIdInfo': {'id': 'PSYC-154-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depressed Participants', 'description': 'No intervention'}, {'label': 'Healthy Control Participants', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Kate Harkness, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queens University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Kate Harkness', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'Harvard University', 'class': 'OTHER'}, {'name': 'McGill University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Kate Harkness', 'investigatorAffiliation': "Queen's University"}}}}