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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 threohydrobupropion

AUC0-24 for racemic bupropion, hydroxybupropion, erythrohydrobupropion and threohydrobupropion

Secondary outcome:

Relapse of MDD

Change 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

Page last updated: August 23, 2015

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