CLINICAL TRIALS PROFILE FOR WELLBUTRIN

All Clinical Trials for Wellbutrin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000457 ↗	Pharmacologic Relapse Prevention for Alcoholic Smokers	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	1998-06-01	This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
NCT00000457 ↗	Pharmacologic Relapse Prevention for Alcoholic Smokers	Completed	Mayo Clinic	Phase 2	1998-06-01	This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
NCT00001483 ↗	Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-06-01	This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales; 1. Inventory for Depressive Symptoms - Clinicians form (IDS-C) 2. Clinical Global Impression scale(CGI-BP) 3. Life Charting Methodology (LCM) Patients who do not respond to their medication within ten weeks from the beginning of the study will be considered as non-responders and be offered the opportunity to start the study again, taking one of the two remaining medications. For example, if a patient was assigned to take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either Zoloft or Effexor. Patients that do respond in the first ten weeks of the study will be eligible to continue taking the medication for one year to assess the long term effectiveness of the drug on preventing episodes of depression and to assess for any possible differential induction of mania.
NCT00044434 ↗	Bupropion as a Smoking Cessation Aid in Alcoholics	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 4	2002-05-01	The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.
NCT00125957 ↗	The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression	Completed	National Association for Research on Schizophrenia and Affective Disorders.	Phase 3	2005-08-01	Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of Wellbutrin (bupropion).
NCT00125957 ↗	The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression	Completed	Mclean Hospital	Phase 3	2005-08-01	Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of Wellbutrin (bupropion).
NCT00126373 ↗	A Trial of Wellbutrin for Crohn's Disease	Completed	GlaxoSmithKline	Phase 2/Phase 3	2005-05-01	The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.

Clinical Trial Conditions for Wellbutrin

Condition Name

Condition Name for Wellbutrin
Intervention	Trials
Major Depressive Disorder	16
Healthy	7
Smoking Cessation	7
Depression	7

Condition MeSH

Condition MeSH for Wellbutrin
Intervention	Trials
Depression	31
Depressive Disorder	29
Depressive Disorder, Major	25
Disease	12

Clinical Trial Locations for Wellbutrin

Trials by Country

Trials by Country for Wellbutrin
Location	Trials
United States	136
Canada	9
Korea, Republic of	4
Estonia	1
Mexico	1

Trials by US State

Trials by US State for Wellbutrin
Location	Trials
New York	14
California	11
Texas	9
Florida	8
North Carolina	6

Clinical Trial Progress for Wellbutrin

Clinical Trial Phase

Clinical Trial Phase for Wellbutrin
Clinical Trial Phase	Trials
Phase 4	34
Phase 3	5
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for Wellbutrin
Clinical Trial Phase	Trials
Completed	58
Recruiting	6
Active, not recruiting	5

Clinical Trial Sponsors for Wellbutrin

Sponsor Name

Sponsor Name for Wellbutrin
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	13
GlaxoSmithKline	10
National Institute of Mental Health (NIMH)	8

Sponsor Type

Sponsor Type for Wellbutrin
Sponsor	Trials
Other	93
NIH	35
Industry	29

Wellbutrin: Clinical Trials, Market Analysis, and Projections

Introduction

Wellbutrin, known generically as bupropion, is a medication widely used for the treatment of major depressive disorder (MDD) and as an aid for smoking cessation. This article will delve into recent clinical trials, market analysis, and future projections for bupropion.

Clinical Trials Update

Recent Trials and Findings

Several recent clinical trials have provided valuable insights into the efficacy and safety of bupropion.

Phase 4 Trials

A Phase 4 trial conducted in 2022 focused on bupropion's efficacy in patients with high inflammation and lack of motivation. This trial compared bupropion to escitalopram and aimed to assess changes in targeted brain connectivity, depressive symptomatology, and motivation. The trial reported side effects such as nausea, itching, anxious mood, and headache, which are consistent with known side effects of bupropion[4].

Bioequivalence Studies

Bioequivalence studies have been crucial in ensuring that generic versions of bupropion are as effective as the branded version, Wellbutrin XL. A notable study sponsored by the FDA in 2010 compared Budeprion XL 300 mg to Wellbutrin XL 300 mg. The results showed that Budeprion XL failed to demonstrate bioequivalence, highlighting issues with generic formulations that may not provide the same therapeutic effect as the branded drug[2][3].

New Formulations: Dextromethorphan/Bupropion (Auvelity)

A recent development in the field is the approval of Auvelity, a combination of dextromethorphan and bupropion, for the treatment of depression. Clinical trials such as ASCEND and GEMINI have shown promising results, with significant improvements in depressive symptoms compared to bupropion alone. These trials, although brief, indicate a potential new avenue for treating MDD[1].

Market Analysis

Global Market Trends

The global bupropion hydrochloride extended-release tablets market is experiencing significant growth. Here are some key trends and projections:

Market Size and Growth

The market for bupropion hydrochloride extended-release tablets is forecasted to grow substantially from 2025 to 2031. The 150mg segment is expected to account for a noticeable share of the global market and is projected to experience significant growth in the near future[5].

Regional Analysis

The market has been segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region is analyzed for revenue share, current trends, and future growth prospects. The hospital segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[5].

Key Players

Companies such as GSK and Slate Run Pharmaceuticals are focusing on strengthening their product portfolios and expanding their business in the global market. These strategies include building robust distribution networks and investing in research and development to enhance product efficacy and safety[5].

Market Projections

Future Outlook

The future outlook for bupropion hydrochloride extended-release tablets is positive, driven by several factors:

Increasing Demand

The demand for bupropion is expected to rise due to the growing prevalence of depression and the need for effective treatment options. The global market is anticipated to witness significant growth, with the hospital segment being a major contributor[5].

Technological Advancements

Technological advancements in drug formulation and delivery systems are likely to improve the efficacy and safety of bupropion. New formulations, such as Auvelity, are expected to play a significant role in the market[1].

Regulatory Environment

Regulatory bodies continue to monitor the bioequivalence of generic bupropion formulations to ensure they meet the standards of the branded versions. This scrutiny is expected to maintain the quality of bupropion products in the market[2][3].

Key Takeaways

• Clinical Trials: Recent trials have focused on the efficacy of bupropion in various patient populations and the bioequivalence of generic formulations.
• Market Growth: The global market for bupropion hydrochloride extended-release tablets is projected to grow significantly from 2025 to 2031.
• New Formulations: The approval of Auvelity (dextromethorphan/bupropion) offers a new treatment option for depression.
• Regional Trends: The hospital segment is expected to be a major contributor to market growth across various regions.
• Regulatory Oversight: Ensuring bioequivalence of generic formulations remains a critical aspect of maintaining drug quality.

FAQs

What is the current status of bupropion in clinical trials?

Bupropion is currently being studied in various clinical trials, including Phase 4 trials that focus on its efficacy in patients with high inflammation and lack of motivation, as well as bioequivalence studies to ensure generic formulations meet the standards of the branded version.

What is Auvelity, and how does it differ from traditional bupropion?

Auvelity is a new formulation that combines dextromethorphan and bupropion. It has shown promising results in clinical trials such as ASCEND and GEMINI, offering a new treatment option for depression with potentially improved efficacy.

What are the common side effects of bupropion?

Common side effects of bupropion include nausea, itching, anxious mood, headache, and dry mouth. These side effects are consistent across various studies and formulations.

How does the FDA ensure the quality of generic bupropion formulations?

The FDA conducts bioequivalence studies to ensure that generic bupropion formulations meet the same therapeutic standards as the branded version, Wellbutrin XL. This involves comparing the rate and extent of absorption of the generic and branded products.

What is the projected market growth for bupropion hydrochloride extended-release tablets?

The global market for bupropion hydrochloride extended-release tablets is forecasted to grow significantly from 2025 to 2031, with the 150mg segment expected to account for a noticeable share of the market.

Sources

1. Middleton, J. (2022, October 24). Meet the newest antidepressant: dextromethorphan/bupropion (Auvelity). American Academy of Family Physicians.
2. Science | AAAS. (2012, October 18). The Generic Wellbutrin Problem: Whose Fault Is It?
3. ClinicalTrials.gov. (2015, November 19). Bioequivalence of Generic Bupropion Ver 1.02.
4. Withpower. (2020, August). Bupropion XL for Depression - Clinical Trials.
5. Cognitive Market Research. (2022, October 17). Bupropion Hydrochloride Extended Release Tablets Market Report 2024 (Global Edition).