Major Depressive Disorder Clinical Trial
— BALANCEOfficial title:
Bioequivalence and Clinical Effects of Generic and Brand Bupropion
Verified date | April 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.
Status | Completed |
Enrollment | 74 |
Est. completion date | August 14, 2016 |
Est. primary completion date | August 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 Structured Clinical Interview for DSM-IV Axis I Disorders (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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion | Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion | For 24 hours approximately every 6 weeks |
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