Depression Clinical Trial
Official title:
Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - a diagnosis of Major Depressive Disorder according to DSM IV or V and validated via Mini International Neuropsychiatric Interview (M.I.N.I.) - right handedness - capability of understanding and finishing self-rating scales - capability of providing informed consent Exclusion Criteria: - any other major psychiatric disorders following DSM-5 diagnostic criteria - neurological diseases - a history of drug abuse - suicidal risk - pregnancy - any contraindication for brain MRI scan. |
Country | Name | City | State |
---|---|---|---|
China | The Second Xiangya Hospital of Central South University | Changsha |
Lead Sponsor | Collaborator |
---|---|
Central South University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Snaith-Hamilton-Pleasure Scale (SHAPES) | 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. | From baseline to 8 weeks | |
Primary | Temporal Experience of Pleasure Scale (TEPS) | 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. | From baseline to 8 weeks | |
Primary | Hamilton Depression Rating scale (HAMD) | Pre-post assessment of depressive symptoms via Hamilton Depression Rating scale (HAMD). Raw score range is 0-52. Higher scores indicate more severe depression. | From baseline to 8 weeks | |
Secondary | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Pre-post assessment of cognitive function via Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | From baseline to 8 weeks | |
Secondary | The Stroop test | Pre-post assessment of cognitive function via the Stroop test. | From baseline to 8 weeks | |
Secondary | Wisconsin Card Sorting Test (WCST) | Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST). | From baseline to 8 weeks | |
Secondary | Rumination Responses Scale | Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes. | From baseline to 8 weeks | |
Secondary | Magnetic Resonance Imaging data | Whole brain Magnetic Resonance Imaging. | From baseline to 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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