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Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

This study has been completed.
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University Identifier:
First received: February 17, 2012
Last updated: April 9, 2014
Last verified: April 2014
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.

Condition Intervention Phase
Major Depressive Disorder
Drug: Bupropion, Escitalopram
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Change from Baseline in Depressive Symptom Scores at 8 Weeks [ Time Frame: Baseline and at 8 Weeks ]
  • Change from Baseline in Depressive Symptom Scores at 4 Weeks [ Time Frame: Baseline and at 4 Weeks ]
  • Change from Baseline in Depressive Symptom Scores at 1 Week [ Time Frame: Baseline and at 1 Week ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 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 [ Time Frame: Baseline and 8 Weeks ]
  • Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach [ Time Frame: Baseline and 8 Weeks ]
  • Number of Participants with Adverse Events [ Time Frame: 4 Weeks ]
  • Number of Participants with Adverse Events [ Time Frame: 8 Weeks ]
  • Changes in Fatigue Severity Scale scores [ Time Frame: Week 8 ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Escitalopram Drug: Escitalopram
Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01541475

Korea, Republic of
Seoul National University Hospital, Biomedical Research Institute
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Ewha Womans University
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Ehwa W. univ hospital
  More Information

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University Identifier: NCT01541475     History of Changes
Other Study ID Numbers: 112063
Study First Received: February 17, 2012
Last Updated: April 9, 2014

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Serotonin Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents processed this record on May 24, 2017