Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Bupropion, Escitalopram; Drug: Escitalopram

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital, Biomedical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Escitalopram	Drug: Escitalopram; Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg
Experimental: Escitalopram + Bupropion	Drug: Bupropion, Escitalopram; Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events	1 Week
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
Number of Participants with Adverse Events	4 Weeks
Number of Participants with Adverse Events	8 Weeks
Changes in Fatigue Severity Scale scores	Week 8

Collaborators and Investigators

• Sponsor: Ewha Womans University
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS, Ehwa W. univ hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Bupropion; Dexetimide
• Other Study ID Numbers: 112063; GSK IIT