Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

NCT01541475 | Completed Phase 4

• 2 other identifiers: 112063GSK IIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Number of Participants with Adverse Events

  1 Week

• 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

• Number of Participants with Adverse Events

  4 Weeks

• Number of Participants with Adverse Events

  8 Weeks

Study Arms (2)

Escitalopram + Bupropion

EXPERIMENTAL

Drug: Bupropion, Escitalopram

Escitalopram

ACTIVE COMPARATOR

Drug: Escitalopram

Interventions

Bupropion, Escitalopram DRUG

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

Escitalopram + Bupropion

Escitalopram DRUG

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

Escitalopram

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Seoul National University Hospital, Biomedical Research Institute

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Bupropion; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• In Kyoon Lyoo, MD, PhD, MMS

  Ehwa W. univ hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 1, 2012
• Study Start: March 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

KR (1)