Major Depressive Disorder
Conditions
Brief summary
The current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (MRI), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
Interventions
DRUGBupropion, Escitalopram
Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg
DRUGEscitalopram
Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg
Sponsors
GlaxoSmithKline
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged between 20 and 65 * Diagnosis of major depressive disorder (MDD) as assessed by the Structured Clinical Interview for DSM-IV (SCID-IV) * Individuals who provided written consent for participation.
Exclusion criteria
* Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.) * Diagnosis of any Axis I disorder other than MDD or presence of symptoms requiring hospitalization * Intelligence quotient (IQ) below 80 * Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.) * Unstable medical illness or other abnormalities observed at the screening or laboratory tests * Women who are pregnant, breastfeeding, or planning pregnancy * Allergy or tolerance to the clinical trial medication * Presence of any physical illness that contraindicates the clinical trial medication (e.g., epilepsy, history of uncontrollable narrow-angle glaucoma) * Use of psychoactive medications that may affect brain imaging findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Depressive Symptom Scores at 8 Weeks | Baseline and at 8 Weeks |
| Change from Baseline in Depressive Symptom Scores at 4 Weeks | Baseline and at 4 Weeks |
| Change from Baseline in Depressive Symptom Scores at 1 Week | Baseline and at 1 Week |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | 1 Week |
| Changes in Fatigue Severity Scale scores | Week 8 |
| Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks | Baseline and 8 Weeks |
| Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach | Baseline and 8 Weeks |
Countries
South Korea
Outcome results
None listed