Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-01 @ 11:48 AM
Study NCT ID:
NCT04977232
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Game Intervention for Anhedonia in MDD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Snaith-Hamilton-Pleasure Scale (SHAPES)', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Pre-post assessment of anhedonia via the Snaith-Hamilton-Pleasure Scale (SHAPES). Raw score range is 14-56. A higher score indicates a worse outcome.'}, {'measure': 'Temporal Experience of Pleasure Scale (TEPS)', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Pre-post assessment of anhedonia via the Temporal Experience of Pleasure Scale (TEPS). Raw score range is 20-120. A lower score indicates a worse outcome.'}, {'measure': 'Hamilton Depression Rating scale (HAMD)', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Pre-post assessment of depressive symptoms via Hamilton Depression Rating scale (HAMD). Raw score range is 0-52. Higher scores indicate more severe depression.'}], 'secondaryOutcomes': [{'measure': 'Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Pre-post assessment of cognitive function via Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).'}, {'measure': 'The Stroop test', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Pre-post assessment of cognitive function via the Stroop test.'}, {'measure': 'Wisconsin Card Sorting Test (WCST)', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST).'}, {'measure': 'Rumination Responses Scale', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes.'}, {'measure': 'Magnetic Resonance Imaging data', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Whole brain Magnetic Resonance Imaging.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This is a pilot study using game intervention as an adjuvant treatment, to evaluate the effect of the video game on anhedonia and associated functional change of brain in patients with depression. Participants will be randomized to Experimental group receiving a 8-week treatment of antidepressant drugs and game intervention, or Control group receiving a 8-week treatment of antidepressant drugs. Magnetic resonance imaging scanning and assessment of clinical characteristics and cognitive function were conducted before and after the intervention.', 'detailedDescription': 'Depression is a serious mental health problem that affects millions of people globally. Anhedonia, a core symptom of depression, is the loss of pleasure or interest in enjoyable activities. The presence of anhedonia is a risk factor of poor outcome of depression. Although some patients reach remission after treatment, anhedonia still persists as a residual symptom. It is generally believed that the frontal-striatal pathway plays an important role in the reward system of brain in patients with depression. The mechanism of anhedonia is closely related to the function of the brain\'s reward system dopamine. There have been some research showed benefits of playing video games on brain. Video games can modulate negative emotions and increase positive feelings. Previous studies have confirmed that playing games will activate the release of dopamine in striatum. "Dancing Line" is a commercial music game. Participants need to change the direction of target according to the music by tapping the screen and manage to finish the routes and get the gems along the route as much as possible. Sometimes the view of participants would change during the game. The game is simple for participants to pick up and there is no need for prior gaming experience. The main purpose of the study is to explore the effect of game as an adjuvant treatment on anhedonia, depressive symptoms, cognitive function and associated functional change of brain in patients with depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a diagnosis of Major Depressive Disorder according to DSM IV or V and validated via Mini International Neuropsychiatric Interview (M.I.N.I.)\n* right handedness\n* capability of understanding and finishing self-rating scales\n* capability of providing informed consent\n\nExclusion Criteria:\n\n* any other major psychiatric disorders following DSM-5 diagnostic criteria\n* neurological diseases\n* a history of drug abuse\n* suicidal risk\n* pregnancy\n* any contraindication for brain MRI scan.'}, 'identificationModule': {'nctId': 'NCT04977232', 'briefTitle': 'Adjunctive Game Intervention for Anhedonia in MDD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LYG2021038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Escitalopram + game intervention', 'description': 'Escitalopram treatment and game intervention are given in combinations for 8 weeks.', 'interventionNames': ['Drug: Escitalopram', 'Behavioral: Game intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Escitalopram', 'description': 'Escitalopram treatment for 8 weeks', 'interventionNames': ['Drug: Escitalopram']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro'], 'description': 'Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.', 'armGroupLabels': ['Escitalopram', 'Escitalopram + game intervention']}, {'name': 'Game intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week.', 'armGroupLabels': ['Escitalopram + game intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Wenbin Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University', 'investigatorFullName': 'Guo Wenbin', 'investigatorAffiliation': 'Central South University'}}}}