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Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Bupropion, Escitalopram

Escitalopram

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital, Biomedical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Escitalopram + Bupropion

Escitalopram

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Depressive Symptom Scores at 8 Weeks

Change from Baseline in Depressive Symptom Scores at 4 Weeks

Change from Baseline in Depressive Symptom Scores at 1 Week

Secondary Outcome Measures

Number of Participants with Adverse Events

Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks

Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach

Number of Participants with Adverse Events

Changes in Fatigue Severity Scale scores

Full Information

NCT ID

NCT01541475

First Posted

February 17, 2012

Last Updated

April 9, 2014

Sponsor

Ewha Womans University

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01541475

Brief Title

Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Official Title

Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ewha Womans University

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escitalopram + Bupropion

Arm Type

Experimental

Arm Title

Escitalopram

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Bupropion, Escitalopram

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline in Depressive Symptom Scores at 8 Weeks

Time Frame

Baseline and at 8 Weeks

Title

Change from Baseline in Depressive Symptom Scores at 4 Weeks

Time Frame

Baseline and at 4 Weeks

Title

Change from Baseline in Depressive Symptom Scores at 1 Week

Time Frame

Baseline and at 1 Week

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Time Frame

1 Week

Title

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

Title

Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach

Time Frame

Baseline and 8 Weeks

Title

Number of Participants with Adverse Events

Time Frame

4 Weeks

Title

Number of Participants with Adverse Events

Time Frame

8 Weeks

Title

Changes in Fatigue Severity Scale scores

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In Kyoon Lyoo, MD, PhD, MMS

Organizational Affiliation

Ehwa W. univ hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital, Biomedical Research Institute

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

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Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

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