Overview

Clinical Study of Generic and Brand Bupropion in Depression

Status:
Completed

Trial end date:
2016-08-14

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Washington University School of Medicine

Treatments:

Bupropion

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 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