Clinical Study of Generic and Brand Bupropion in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Bupropion XL 300
Intervention description: 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).
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Each participant receives the 4 drugs in sequence (sequence is randomized).
Masking: Double (Participant, Care Provider)
Masking description: The randomization table will be generated by the Barnes-Jewish Hospital Investigational Pharmacy. Each subject will be assigned the next available number. Subjects, investigators, and all study team members will be blinded to drug treatment. In the case of dropouts (either subject- or investigator-initiated), subjects will be replaced, to provide the required number of subjects.
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; bupropion XL; Wellbutrin XL

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.
    

Eligibility 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