Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01541475
First received: February 17, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Depressive Symptom Scores at 4 Weeks [ Time Frame: Baseline and at 4 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Depressive Symptom Scores at 1 Week [ Time Frame: Baseline and at 1 Week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 1 Week ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
  • 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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01541475     History of Changes
Other Study ID Numbers: 112063, GSK IIT
Study First Received: February 17, 2012
Last Updated: April 9, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on August 21, 2014