Clinical Study of Generic and Brand Bupropion in Depression

Study Overview
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Brief Summary
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Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.

Detailed Description
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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).

Official Title
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Bioequivalence and Clinical Effects of Generic and Brand Bupropion

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Bupropion XL 300


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Each participant receives the 4 drugs in sequence (sequence is randomized).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StudyArm<br>Subjects will be studied for 28 weeks in a sequential cross-over study: a 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). | Drug: Bupropion XL 300<br>* 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).<br>* Other names: Valeant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, bupropion XL, Wellbutrin XL