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Completed

NCT Number: NCT01541475

Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital, Biomedical Research Institute

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Change from Baseline in Depressive Symptom Scores at 8 Weeks

    Time frame: Baseline and at 8 Weeks

  2. Change from Baseline in Depressive Symptom Scores at 4 Weeks

    Time frame: Baseline and at 4 Weeks

  3. Change from Baseline in Depressive Symptom Scores at 1 Week

    Time frame: Baseline and at 1 Week

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: 1 Week

  2. 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

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

    Time frame: Baseline and 8 Weeks

  4. Number of Participants with Adverse Events

    Time frame: 4 Weeks

  5. Number of Participants with Adverse Events

    Time frame: 8 Weeks

  6. Changes in Fatigue Severity Scale scores

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 1, 2012
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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