Major Depressive DisorderPhase 4BALANCENCT02209597

Clinical Study of Generic and Brand Bupropion in Depression

A Phase 4 study testing Bupropion XL 300 in people with Major Depressive Disorder, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Bupropion XL 300
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 25 Jun 2014to 14 Aug 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Bioequivalence and Clinical Effects of Generic and Brand Bupropion

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

Read the 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).

Conditions: Major Depressive Disorder
Being tested: Bupropion XL 300
Keywords: Major Depressive Disorder, bupropion XL, Wellbutrin XL
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupropion XL 300Drug
Also called Wellbutrin, Par, Mylan, Valeant
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).

Study groups in NCT02209597
Study group	Role	What they receive
StudyArm	Experimental	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). Receives: Drug: Bupropion XL 300

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion
Measured: For 24 hours approximately every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 201414 Aug 2016

First posted6 Aug 2014 (estimated)
Study start25 Jun 2014
Primary completion14 Aug 2016
Study completion14 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Each participant receives the 4 drugs in sequence (sequence is randomized).
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02209597
Sponsor's protocol ID: 201312021
Acronym: BALANCE
Status last verified: Apr 2020
First submitted: 7 Jul 2014
Last updated: 24 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Kharasch ED, Lenze EJ. Pharmacogenetic Influence on Stereoselective Steady-State Disposition of Bupropion. Drug Metab Dispos. 2024 Apr 16;52(5):455-466. doi: 10.1124/dmd.124.001697.
PubMed 38467432

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence and Clinical Effects of Generic and Brand Bupropion
ClinicalTrials.gov ID: NCT02209597
Acronym / sponsor ID: BALANCE / 201312021
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, bupropion XL, Wellbutrin XL
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 25 Jun 2014 (actual)
Primary completion: 14 Aug 2016 (actual)
Study completion: 14 Aug 2016 (actual)
First posted: 6 Aug 2014 (estimated)
Results: Posted 24 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, care provider)
Number of arms: 1
Model description: Each participant receives the 4 drugs in sequence (sequence is randomized).

Arm	Type	Receives
StudyArm	Experimental	Drug: Bupropion XL 300Subjects 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).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupropion XL 300Also: Wellbutrin, Par, Mylan, ValeantSubjects 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	StudyArm

Primary outcome

Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion
Time frame: For 24 hours approximately every 6 weeks
Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion

Results and safety

Results posted to the registry on 24 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bupropion	74	71

Primary outcome: Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion

Time frame: For 24 hours approximately every 6 weeks. Mean (Full Range). Unit: percentage of Brand

Measure	Valeant Brand Bupropion XL® 300mg n = 67	Par Generic Bupropion XL® 300mg n = 67	Watson Generic Bupropion XL® 300mg n = 67	Mylan Generic Bupropion XL® 300mg n = 67
Bupropion	.84 (.71 to 1.04)	.88 (.72 to 1.08)	.83 (.68 to .99)	.89 (.7 to 1.06)
Hydroxybupropion	20.9 (15.5 to 25.5)	20.9 (15.9 to 28.1)	21.8 (15.9 to 26.5)	21.6 (15.9 to 27.7)
Erthrohydrobuprion	2.09 (1.52 to 2.59)	2.05 (1.47 to 2.57)	1.98 (1.48 to 2.34)	2.02 (1.61 to 2.50)
Threohydrobupropion	9.38 (7.21 to 13.27)	9.05 (7.21 to 13.27)	8.57 (6.83 to 11.57)	8.78 (7.25 to 12.49)

Valeant Brand Bupropion XL® 300mg vs Par Generic Bupropion XL® 300mg vs Watson Generic Bupropion XL® 300mg vs Mylan Generic Bupropion XL® 300mg: p <0.05, ANOVA

Adverse events

Time frame: 28 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valeant Brand Bupropion XL® 300mg	0 of 71 (0%)	0 of 71 (0%)	0 of 71
PAR Generic Bupropion XL® 300mg	0 of 71 (0%)	0 of 71 (0%)	0 of 71
Watson Generic Bupropion XL® 300mg	0 of 71 (0%)	1 of 71 (1.4%)	0 of 71
Mylan Generic Bupropion XL® 300mg	0 of 71 (0%)	0 of 71 (0%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38467432Kharasch ED, Lenze EJ. Pharmacogenetic Influence on Stereoselective Steady-State Disposition of Bupropion. Drug Metab Dispos. 2024 Apr 16;52(5):455-466. doi: 10.1124/dmd.124.001697.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Evan D Kharasch, MD, PhD principal investigator

Washington Univesity School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupropion XL 300 in people with Major Depressive Disorder, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion (time frame: For 24 hours approximately every 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02209597, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.