Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Bupropion, Escitalopram; Drug: Escitalopram

• Registration Number: NCT01541475
• Lead Sponsor: Ewha Womans University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-03-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram + Bupropion	Bupropion, Escitalopram	-
Escitalopram	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of Participants with Adverse Events	8 Weeks
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
Changes in Fatigue Severity Scale scores	Week 8

Trial Locations

Locations (1)

Seoul National University Hospital, Biomedical Research Institute; 🇰🇷 Seoul, Korea, Republic of