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Antidepressant
Bupropion XL for Depression
Phase 4
Waitlist Available
Led By Andrew Miller, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4, week 6, week 8
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial is testing bupropion and escitalopram in depressed patients with high inflammation and lack of motivation. It aims to see if bupropion, which increases dopamine, is more effective than escitalopram, which increases serotonin. Escitalopram is known for its superior efficacy and tolerability in treating major depressive disorder compared to other similar medications.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 4, week 6, week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4, week 6, week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Targeted Ventromedial Prefrontal Cortex-Ventral Striatal (vmPFC-VS) Functional Connectivity (FC)
Secondary study objectives
Inventory of Depressive Symptomatology - Self-Report (IDS-SR)
Motivation and Pleasure Scale-Self-Report (MAP-SR) Score
Proportion of Hard-Task Choices During the Effort-Expenditure for Rewards Task (EEfRT)
+1 moreSide effects data
From 2022 Phase 4 trial • 18 Patients • NCT0435210120%
Nausea
20%
Itching
20%
Anxious mood
10%
Insomnia
10%
Stress
10%
High blood pressure
10%
Nocturnal perspiration
10%
Chest pain
10%
Lightheadedness
10%
Headache
10%
Dry mouth
10%
Enlarged lymph nodes
10%
Pain in limb
10%
Vivid dreams
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bupropion
Escitalopram
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BupropionExperimental Treatment1 Intervention
Participants randomized to take bupropion for 8 weeks.
Group II: EscitalopramActive Control1 Intervention
Participants randomized to take escitalopram for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion XL
2009
Completed Phase 4
~370
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,900 Total Patients Enrolled
62 Trials studying Depression
9,582 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,947 Total Patients Enrolled
701 Trials studying Depression
261,133 Patients Enrolled for Depression
Andrew Miller, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
374 Total Patients Enrolled
1 Trials studying Depression
20 Patients Enrolled for Depression
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