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Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01541475
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : April 10, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Bupropion, Escitalopram Drug: Escitalopram Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
Study Start Date : March 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 1 Week ]
  2. 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 ]
  3. Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach [ Time Frame: Baseline and 8 Weeks ]
  4. Number of Participants with Adverse Events [ Time Frame: 4 Weeks ]
  5. Number of Participants with Adverse Events [ Time Frame: 8 Weeks ]
  6. Changes in Fatigue Severity Scale scores [ Time Frame: Week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541475


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

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01541475     History of Changes
Other Study ID Numbers: 112063
GSK IIT
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Bupropion
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Dopamine Uptake Inhibitors