Bupropion Depression
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Wellbutrin XL® 300mg (Drug); 300mg bupropion XL 1 (Drug); 300mg bupropion XL 2 (Drug); 300mg bupropion XL 3 (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Evan D Kharasch, MD, PhD, Principal Investigator, Affiliation: Washington Univesity School of Medicine
Overall contact:
Angie Stevens, Phone: 314-362-3519, Email: stevensa@psychiatry.wustl.edu
Summary
Determine bioequivalence between branded and generic bupropion extended release (XL)
products (and between generic products) at steady state in patients with major depressive
disorder.
Clinical Details
Official title: Bioequivalence and Clinical Effects of Generic and Brand Bupropion
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Primary outcome: Cmax for racemic bupropion, hydroxybupropion, erythrohydrobupropion and threohydrobupropionAUC0-24 for racemic bupropion, hydroxybupropion, erythrohydrobupropion and threohydrobupropion
Secondary outcome: Relapse of MDDChange in symptoms of depression Change in side effects of medication
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
Each subject must meet all of the following criteria:
1. Adult outpatients age 18-75 years
2. Currently on once daily bupropion HCl 300mg XL (brand or any generic), for a minimum
of 4 months
3. Major depressive disorder (MDD), in partial or full remission for at least 4 months,
as confirmed by the SCID. Spontaneous relapse of depression unrelated to medication
changes is less likely - about 5% chance per year - after remission has been
maintained for at least 4 months. 2
4. Ability to understand and willingness to comply with study procedures, and to provide
written informed consent
Exclusion Criteria
Subjects will not be enrolled if any of the following criteria exist:
1. Remission from depression not clearly attributed to bupropion treatment
2. Current severe side effects attributable to bupropion
3. Poor adherence to bupropion treatment per patient self- report and history of refill
persistence
4. History of active seizure disorder, or seizure treatment within past year
5. History of significant hepatic or renal disease, based on physician assessment
6. Currently taking drugs or natural products known to influence cytochrome P450B6
(CYP2B6) activity
7. Currently taking drugs for hepatitis C or multiple sclerosis, due to their ability to
cause depression
8. Dementia or other significant cognitive impairment, per diagnosis or investigative
team's assessment
9. Lifetime diagnosis of schizophrenia, schizoaffective or schizophreniform dis-order,
delusional disorder, or current psychotic symptoms diagnosed by SCID
10. Abuse of or dependence on alcohol or other substances within the past 6 months as
determined by SCID, and confirmed by study physician interview
11. Current suicidal ideation
Locations and Contacts
Angie Stevens, Phone: 314-362-3519, Email: stevensa@psychiatry.wustl.edu
Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Evan D Kharasch, MD, PhD, Principal Investigator
Eric Lenze, MD, Sub-Investigator
Additional Information
Starting date: June 2014
Last updated: June 2, 2015
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