Clinical Study of Generic and Brand Bupropion in Depression

NCT02209597 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 201312021
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; bupropion XL; Wellbutrin XL

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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).

Drug: Bupropion XL 300

Interventions

Bupropion XL 300 DRUG

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).

Also known as: Wellbutrin, Par, Mylan, Valeant

StudyArm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Bupropion; Pregnane X Receptor

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Receptors, Steroid; Receptors, Cytoplasmic and Nuclear; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Results Point of Contact

• Title: Evan Kharasch MD PhD
• Organization: Washington University

kharasch@wustl.edu

3143628796

Study Officials

• Evan D Kharasch, MD, PhD

  Washington Univesity School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant receives the 4 drugs in sequence (sequence is randomized).

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: August 6, 2014
• Study Start: June 25, 2014
• Primary Completion: August 14, 2016
• Study Completion: August 14, 2016
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Locations

US (1)