DepressionNCT04977232
Adjunctive Game Intervention for Anhedonia in MDD Patients
A study testing Escitalopram and Game intervention in people with Depression, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram and Game intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Escitalopram, Game intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.
Game interventionBehavioural
Participants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram + game intervention | Experimental | Escitalopram treatment and game intervention are given in combinations for 8 weeks. Receives: Drug: Escitalopram; Behavioral: Game intervention |
| Escitalopram | Active comparator | Escitalopram treatment for 8 weeks Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 8 weeks
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.
Measured: From baseline to 8 weeks
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.
Measured: From baseline to 8 weeks
Secondary outcomes (5)
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).
Measured: From baseline to 8 weeks
The Stroop test
Pre-post assessment of cognitive function via the Stroop test.
Measured: From baseline to 8 weeks
Wisconsin Card Sorting Test (WCST)
Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST).
Measured: From baseline to 8 weeks
Rumination Responses Scale
Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes.
Measured: From baseline to 8 weeks
Magnetic Resonance Imaging data
Whole brain Magnetic Resonance Imaging.
Measured: From baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start9 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Wenbin, Central South University
- Investigators
- Wenbin Guo, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977232
- Sponsor's protocol ID
- LYG2021038
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04977232
- Acronym / sponsor ID
- LYG2021038
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram + game intervention | Experimental | Drug: Escitalopram, Behavioral: Game interventionEscitalopram treatment and game intervention are given in combinations for 8 weeks. |
| Escitalopram | Active comparator | Drug: EscitalopramEscitalopram treatment for 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- any other major psychiatric disorders following DSM-5 diagnostic criteria
- neurological diseases
- a history of drug abuse
- suicidal risk
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: LexaproSelective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression. | Drug | Escitalopram, Escitalopram + game intervention |
| Game interventionParticipants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week. | Behavioural | Escitalopram + game intervention |
Primary outcome
Snaith-Hamilton-Pleasure Scale (SHAPES)
Time frame: From baseline to 8 weeks
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)
Time frame: From baseline to 8 weeks
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)
Time frame: From baseline to 8 weeks
Pre-post assessment of depressive symptoms via Hamilton Depression Rating scale (HAMD). Raw score range is 0-52. Higher scores indicate more severe depression.
5 secondary outcomes
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: From baseline to 8 weeks
The Stroop test
Time frame: From baseline to 8 weeks
Wisconsin Card Sorting Test (WCST)
Time frame: From baseline to 8 weeks
Rumination Responses Scale
Time frame: From baseline to 8 weeks
Magnetic Resonance Imaging data
Time frame: From baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenbin Guo principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram and Game intervention in people with Depression, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snaith-Hamilton-Pleasure Scale (SHAPES) (time frame: From baseline to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.