Clinical trial NCT01541475: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in Depressive Symptom Scores at 8 Weeks
timeFrame: Baseline and at 8 Weeks
measure: Change from Baseline in Depressive Symptom Scores at 4 Weeks
timeFrame: Baseline and at 4 Weeks
measure: Change from Baseline in Depressive Symptom Scores at 1 Week
timeFrame: Baseline and at 1 Week
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 1 Week
measure: Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks
timeFrame: Baseline and 8 Weeks
measure: Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach
timeFrame: Baseline and 8 Weeks
measure: Number of Participants with Adverse Events
timeFrame: 4 Weeks
measure: Number of Participants with Adverse Events
timeFrame: 8 Weeks
measure: Changes in Fatigue Severity Scale scores
timeFrame: Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Biomedical Research Institute
Study officials:
affiliation: Ehwa W. univ hospital
name: In Kyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References: