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Adjunctive Game Intervention for Anhedonia in MDD Patients

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Escitalopram
Game intervention
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Escitalopram + game intervention

Escitalopram

Arm Description

Escitalopram treatment and game intervention are given in combinations for 8 weeks.

Escitalopram treatment for 8 weeks

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
The Stroop test
Pre-post assessment of cognitive function via the Stroop test.
Wisconsin Card Sorting Test (WCST)
Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST).
Rumination Responses Scale
Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes.
Magnetic Resonance Imaging data
Whole brain Magnetic Resonance Imaging.

Full Information

First Posted
July 13, 2021
Last Updated
July 19, 2022
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04977232
Brief Title
Adjunctive Game Intervention for Anhedonia in MDD Patients
Official Title
Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram + game intervention
Arm Type
Experimental
Arm Description
Escitalopram treatment and game intervention are given in combinations for 8 weeks.
Arm Title
Escitalopram
Arm Type
Active Comparator
Arm Description
Escitalopram treatment for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.
Intervention Type
Behavioral
Intervention Name(s)
Game intervention
Intervention Description
Participants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week.
Primary Outcome Measure Information:
Title
Snaith-Hamilton-Pleasure Scale (SHAPES)
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.
Time Frame
From baseline to 8 weeks
Title
Temporal Experience of Pleasure Scale (TEPS)
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.
Time Frame
From baseline to 8 weeks
Title
Hamilton Depression Rating scale (HAMD)
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.
Time Frame
From baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
Pre-post assessment of cognitive function via Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Time Frame
From baseline to 8 weeks
Title
The Stroop test
Description
Pre-post assessment of cognitive function via the Stroop test.
Time Frame
From baseline to 8 weeks
Title
Wisconsin Card Sorting Test (WCST)
Description
Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST).
Time Frame
From baseline to 8 weeks
Title
Rumination Responses Scale
Description
Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes.
Time Frame
From baseline to 8 weeks
Title
Magnetic Resonance Imaging data
Description
Whole brain Magnetic Resonance Imaging.
Time Frame
From baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Guo
Phone
+8613875936768
Email
guowenbin76@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbin Guo
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Guo, professor
Email
guowenbin76@csu.edu.cn

12. IPD Sharing Statement

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Adjunctive Game Intervention for Anhedonia in MDD Patients

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