Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

This study is not yet open for participant recruitment.
Verified February 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01541475
First received: February 17, 2012
Last updated: February 23, 2012
Last verified: February 2012

February 17, 2012
February 23, 2012
February 2012
September 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01541475 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Bupropion, Escitalopram
    Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg
  • Drug: Escitalopram
    Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg
  • Experimental: Escitalopram + Bupropion
    Intervention: Drug: Bupropion, Escitalopram
  • Active Comparator: Escitalopram
    Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact: Junghyun H Lee, M.D. +82-10-3453-1744 leejunghyun1@gmail.com
Korea, Republic of
 
NCT01541475
112063, GSK IIT
Yes
In Kyoon Lyoo, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Seoul National University Hospital
Seoul National University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP