Clinical Study of Generic and Brand Bupropion in Depression

The protocol is a prospective, randomized, double-blinded, crossover study with Major Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic).

Subjects will be studied in 4 phases for a total of approximately 28 weeks:

Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).

Inclusion criteria

Each subject must meet all of the following criteria:

• Adult outpatients age 18-75 years
• Currently on once daily bupropion HCl 300mg XL (brand or any generic), for a minimum of 4 months
• 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
• 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:

• Remission from depression not clearly attributed to bupropion treatment
• Current severe side effects attributable to bupropion
• Poor adherence to bupropion treatment per patient self- report and history of refill persistence
• History of active seizure disorder, or seizure treatment within past year
• History of significant hepatic or renal disease, based on physician assessment
• Currently taking drugs or natural products known to influence cytochrome P450B6 (CYP2B6) activity
• Currently taking drugs for hepatitis C or multiple sclerosis, due to their ability to cause depression
• Dementia or other significant cognitive impairment, per diagnosis or investigative team's assessment
• Lifetime diagnosis of schizophrenia, schizoaffective or schizophreniform dis-order, delusional disorder, or current psychotic symptoms diagnosed by SCID
• Abuse of or dependence on alcohol or other substances within the past 6 months as determined by SCID, and confirmed by study physician interview
• Current suicidal ideation