Clinical Study of Generic and Brand Bupropion in Depression

Major Depressive Disorder Clinical Trial

— BALANCE  

Official title:

Bioequivalence and Clinical Effects of Generic and Brand Bupropion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209597
• Other study ID #: 201312021
• Status: Completed
• Phase: Phase 4
• Start date: June 25, 2014
• Est. completion date: August 14, 2016

Study information

• Verified date: April 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 14, 2016
• Est. primary completion date: August 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Bupropion XL 300
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).

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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