Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541475
• Other study ID #: 112063
• Secondary ID: GSK IIT
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2012
• Last updated: April 9, 2014
• Start date: March 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2014
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Biomedical Research Institute	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Ewha Womans University	GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Depressive Symptom Scores at 8 Weeks		Baseline and at 8 Weeks	No
Primary	Change from Baseline in Depressive Symptom Scores at 4 Weeks		Baseline and at 4 Weeks	No
Primary	Change from Baseline in Depressive Symptom Scores at 1 Week		Baseline and at 1 Week	No
Secondary	Number of Participants with Adverse Events		1 Week	Yes
Secondary	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	No
Secondary	Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach		Baseline and 8 Weeks	No
Secondary	Number of Participants with Adverse Events		4 Weeks	Yes
Secondary	Number of Participants with Adverse Events		8 Weeks	Yes
Secondary	Changes in Fatigue Severity Scale scores		Week 8