Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

NCT ID: NCT01541475

Last Updated: 2014-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Escitalopram + Bupropion

Group Type EXPERIMENTAL

Bupropion, Escitalopram

Intervention Type DRUG

Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg

Escitalopram

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg

Interventions

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Bupropion, Escitalopram

Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg

Intervention Type DRUG

Escitalopram

Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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In Kyoon Lyoo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In Kyoon Lyoo, MD, PhD, MMS

Role: PRINCIPAL_INVESTIGATOR

Ehwa W. univ hospital

Locations

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Seoul National University Hospital, Biomedical Research Institute

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GSK IIT

Identifier Type: -

Identifier Source: secondary_id

112063

Identifier Type: -

Identifier Source: org_study_id

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