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Clinical Study of Generic and Brand Bupropion in Depression (BALANCE)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupropion XL 300
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, bupropion XL, Wellbutrin XL

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

StudyArm

Arm Description

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).

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion

Secondary Outcome Measures

Full Information

First Posted
July 7, 2014
Last Updated
April 23, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02209597
Brief Title
Clinical Study of Generic and Brand Bupropion in Depression
Acronym
BALANCE
Official Title
Bioequivalence and Clinical Effects of Generic and Brand Bupropion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 25, 2014 (Actual)
Primary Completion Date
August 14, 2016 (Actual)
Study Completion Date
August 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, bupropion XL, Wellbutrin XL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
Each participant receives the 4 drugs in sequence (sequence is randomized).
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
StudyArm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Bupropion XL 300
Other Intervention Name(s)
Wellbutrin, Par, Mylan, Valeant
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).
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Description
Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion
Time Frame
For 24 hours approximately every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan D Kharasch, MD, PhD
Organizational Affiliation
Washington Univesity School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of Generic and Brand Bupropion in Depression

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