Adjunctive Game Intervention for Anhedonia in MDD Patients

NCT04977232 | Completed

• 1 other identifier: LYG2021038
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  From baseline to 8 weeks

• The Stroop test

  From baseline to 8 weeks

• Wisconsin Card Sorting Test (WCST)

  From baseline to 8 weeks

• Rumination Responses Scale

  From baseline to 8 weeks

• Magnetic Resonance Imaging data

  From baseline to 8 weeks

Study Arms (2)

Escitalopram + game intervention

EXPERIMENTAL

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

Drug: Escitalopram; Behavioral: Game intervention

Escitalopram

ACTIVE COMPARATOR

Escitalopram treatment for 8 weeks

Drug: Escitalopram

Interventions

Escitalopram DRUG

Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.

Also known as: Lexapro

Escitalopram; Escitalopram + game intervention

Game intervention BEHAVIORAL

Participants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week.

Escitalopram + game intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, China

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wenbin Guo

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 26, 2021
• Study Start: September 9, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)