Depressive Symptoms Responding to Bupropion A Differential Item Functioning Approach in Patients with Major Depressive Disorder

Lead Investigator: Manit Srisurapanont, Chiang Mai University Faculty of Medicine
Title of Proposal Research: Depressive Symptoms Responding to Bupropion A Differential Item Functioning Approach in Patients with Major Depressive Disorder
Vivli Data Request: 8750
Funding Source: Chiang Mai University Fund
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Major depressive disorder (MDD) is a mental health condition characterized by persistent feelings of sadness, hopelessness, and loss of interest in activities. Other symptoms can include changes in appetite and sleep, fatigue, difficulty concentrating, and thoughts of suicide. MDD is a leading cause of disability and is estimated to affect around 350 million people worldwide.

Treatment for MDD typically involves medications and/or psychotherapy. Different types of antidepressant medications, which work via various mechanisms, are frequently prescribed to alleviate symptoms. These medications include selective serotonin reuptake inhibitors (SSRIs, e.g., escitalopram), norepinephrine-dopamine reuptake inhibitors (NDRIs, e.g., bupropion), and others. SSRIs work by increasing serotonin activity in the brain. Serotonin is a neurotransmitter (a chemical messenger that carries signals between nerve cells in the brain). It is thought to have a good influence on mood, emotion, and sleep. NDRIs increase the activities of two other neurotransmitters, noradrenaline and dopamine which also have a positive effect on mood. Psychotherapy, such as cognitive-behavioral therapy (CBT), can also be effective in managing MDD.

It is important to note that each person’s experience with MDD is unique. The medication that works for one person may not work for another. It may take some trial and error to find the right medication for a person. It is hypothesized that different mechanisms of antidepressants may effect different symptoms of depression.

Previous studies have used simple statistical techniques to compare the affects of different antidepressants. However, those simple techniques do not take into account the different levels of depression severity between groups, e.g., the less severe group (receiving antidepressants) vs. the more severe group (receiving placebo), which is an unfair comparison. In contrast, a more advanced statistical technique called “Differential Item Functioning (DIF) Analysis” can compare the symptoms between groups while taking into account differences in depression severity levels. The results of this advanced analysis should, therefore, be more valid than the simple statistical analyses applied previously. We propose that this technique can be used to determine if there are differences in the symptoms that respond to different antidepressants such as bupropion and escitalopram.

Requested Studies:

Study AK1113351, a Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD) – a Multi-center, Placebo-controlled, Randomized, Double-blind, Parallel-comparison Study
Data Contributor: GSK
Study ID: NCT01138007
Sponsor ID: 113351

A Multi-centre, Randomised, Double-blind, Parallel Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release (Bupropion XL 300mg Once Daily), Escitalopram Oxalate (Escitalopram, 10mg-20mg Once Daily) in Subjects With Major Depressive Disorder
Data Contributor: GSK
Study ID: NCT02191397
Sponsor ID: 114589