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Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR WELLBUTRIN SR


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All Clinical Trials for WELLBUTRIN SR

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for WELLBUTRIN SR

Condition Name

1677700246810121416Major Depressive DisorderDepressionHealthySmoking Cessation[disabled in preview]
Condition Name for WELLBUTRIN SR
Intervention Trials
Major Depressive Disorder 16
Depression 7
Healthy 7
Smoking Cessation 7
[disabled in preview] 0
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Condition MeSH

312925120051015202530DepressionDepressive DisorderDepressive Disorder, MajorDisease[disabled in preview]
Condition MeSH for WELLBUTRIN SR
Intervention Trials
Depression 31
Depressive Disorder 29
Depressive Disorder, Major 25
Disease 12
[disabled in preview] 0
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Clinical Trial Locations for WELLBUTRIN SR

Trials by Country

+
Trials by Country for WELLBUTRIN SR
Location Trials
United States 136
Canada 9
Korea, Republic of 4
Malaysia 1
Kenya 1
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Trials by US State

+
Trials by US State for WELLBUTRIN SR
Location Trials
New York 14
California 11
Texas 9
Florida 8
North Carolina 6
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Clinical Trial Progress for WELLBUTRIN SR

Clinical Trial Phase

42.0%6.2%9.9%42.0%05101520253035Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for WELLBUTRIN SR
Clinical Trial Phase Trials
Phase 4 34
Phase 3 5
Phase 2/Phase 3 8
[disabled in preview] 34
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Clinical Trial Status

69.0%7.1%6.0%17.9%0051015202530354045505560CompletedRecruitingActive, not recruiting[disabled in preview]
Clinical Trial Status for WELLBUTRIN SR
Clinical Trial Phase Trials
Completed 58
Recruiting 6
Active, not recruiting 5
[disabled in preview] 15
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Clinical Trial Sponsors for WELLBUTRIN SR

Sponsor Name

trials0246810121416182022National Institute on Drug Abuse (NIDA)GlaxoSmithKlineNational Institute of Mental Health (NIMH)[disabled in preview]
Sponsor Name for WELLBUTRIN SR
Sponsor Trials
National Institute on Drug Abuse (NIDA) 13
GlaxoSmithKline 10
National Institute of Mental Health (NIMH) 8
[disabled in preview] 20
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Sponsor Type

59.2%22.3%18.5%00102030405060708090100OtherNIHIndustry[disabled in preview]
Sponsor Type for WELLBUTRIN SR
Sponsor Trials
Other 93
NIH 35
Industry 29
[disabled in preview] 0
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Wellbutrin SR: Clinical Trials, Market Analysis, and Projections

Introduction to Wellbutrin SR

Wellbutrin SR, also known as bupropion hydrochloride, is a prescription medication primarily used for the treatment of major depressive disorder (MDD). It is available in a sustained-release (SR) formulation, which releases the active drug slowly into the body over time.

Clinical Trials and Efficacy

Efficacy in Major Depressive Disorder

The efficacy of Wellbutrin SR in treating major depressive disorder has been established through several clinical trials. These trials include two 4-week controlled inpatient trials and one 6-week controlled outpatient trial, which demonstrated the effectiveness of bupropion in treating adult subjects with MDD[1].

Maintenance Treatment

A placebo-controlled trial showed that Wellbutrin SR is effective in maintaining an antidepressant response for up to 44 weeks following an initial 8 weeks of acute treatment. This indicates the drug's long-term efficacy in managing depression[1].

Bioequivalence Studies

Bioequivalence studies are crucial for ensuring that generic versions of Wellbutrin SR are as safe and effective as the brand-name version. A notable study by the FDA found that the generic version of Wellbutrin XL (300 mg) made by Impax Laboratories and distributed by Teva Pharmaceuticals was not bioequivalent to the brand-name Wellbutrin XL at the same dose. This led to the removal of this generic version from the market due to reports of reduced efficacy and worsening depressive symptoms[2][3].

However, bioequivalence has been established for Wellbutrin SR and other generic versions of bupropion SR at various dosages, including 100 mg, 150 mg, and 200 mg[3].

Dosage and Administration

General Dosage Guidelines

The starting dose for Wellbutrin SR is typically 150 mg/day, given as a single daily dose in the morning. After 3 days, the dose can be increased to 300 mg/day, given as 150 mg twice daily, with an interval of at least 8 hours between doses. The maximum dose is 400 mg/day, given as 200 mg twice daily, for patients who do not respond to the 300 mg/day dose[1].

Special Considerations

For patients with moderate to severe hepatic impairment, the maximum dose is 100 mg/day or 150 mg every other day. For those with mild hepatic impairment, a reduction in dose and/or frequency of dosing is recommended. Similarly, for patients with renal impairment, dose adjustments may be necessary[1].

Market Analysis

Global Market Trends

The global market for bupropion hydrochloride extended-release tablets is experiencing significant growth. The 150 mg segment of the market accounted for a noticeable share in 2023 and is projected to continue growing in the near future. The hospital segment is expected to expand at a significant compound annual growth rate (CAGR) throughout the forecast period[5].

Key Players

Several pharmaceutical companies are active in the bupropion hydrochloride market, including GlaxoSmithKline (GSK), Novartis (Sandoz), Slate Run Pharmaceuticals, Teva Pharmaceutical, and others. These companies are focusing on strategies to strengthen their product portfolios and expand their business globally[5].

Market Segmentation

The market is segmented by type (150 mg, 300 mg, others) and application (hospitals, clinics, others). This segmentation helps in understanding the key industry segments and their growth prospects at the global, regional, and country levels[5].

Projections and Future Outlook

Market Growth

The global bupropion hydrochloride extended-release tablets market is forecasted to grow significantly from 2025 to 2031. The report by Cognitive Market Research provides detailed insights into market trends, opportunities, and challenges. It also includes an analysis of the manufacturing process, major raw materials, and the competitive landscape[5].

Regional Analysis

The market has been segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region's revenue share, current trends, and future prospects are analyzed to provide a comprehensive understanding of the market[5].

Side Effects and Safety Considerations

Common Side Effects

Wellbutrin SR can cause several side effects, including headache, fatigue, and anxiety. Weight loss is also a common side effect, although the drug is not approved for use as a weight loss medication[4].

Seizure Risk

One of the significant safety concerns with Wellbutrin SR is the risk of seizures. To minimize this risk, the dose should be increased gradually. Patients should also be advised not to crush, divide, or chew the tablets[1].

Monitoring and Precautions

Families and caregivers of patients taking Wellbutrin SR should be alerted to monitor for signs of worsening depression, suicidality, agitation, irritability, and unusual changes in behavior. Daily observation and immediate reporting of such symptoms to healthcare providers are crucial[1].

Key Takeaways

  • Efficacy: Wellbutrin SR is effective in treating major depressive disorder and maintaining antidepressant response over long periods.
  • Dosage: The usual target dose is 300 mg/day, given as 150 mg twice daily, with adjustments for hepatic and renal impairments.
  • Market Growth: The global market for bupropion hydrochloride extended-release tablets is projected to grow significantly from 2025 to 2031.
  • Safety: Gradual dose increase is necessary to minimize seizure risk, and patients should be monitored for signs of worsening depression and other adverse effects.

FAQs

What is the typical dosage for Wellbutrin SR?

The typical starting dose for Wellbutrin SR is 150 mg/day, which can be increased to 300 mg/day given as 150 mg twice daily after 3 days. The maximum dose is 400 mg/day[1].

Why was a generic version of Wellbutrin XL removed from the market?

A generic version of Wellbutrin XL (300 mg) made by Impax Laboratories and distributed by Teva Pharmaceuticals was removed from the market due to findings that it was not bioequivalent to the brand-name version, leading to reduced efficacy and worsening depressive symptoms[2].

What are the common side effects of Wellbutrin SR?

Common side effects include headache, fatigue, and anxiety. Weight loss is also a frequent side effect, although the drug is not approved for weight loss[4].

How long does it take for Wellbutrin SR to leave the body?

The half-life of Wellbutrin is about 21 hours, meaning it takes approximately 105 hours (around 4 days) for the drug to be completely eliminated from the body[4].

What are the key players in the bupropion hydrochloride market?

Key players include GSK, Novartis (Sandoz), Slate Run Pharmaceuticals, Teva Pharmaceutical, and others[5].

What is the projected growth of the bupropion hydrochloride market?

The global market for bupropion hydrochloride extended-release tablets is forecasted to grow significantly from 2025 to 2031, with the 150 mg segment and hospital segment expected to expand at a significant CAGR[5].

Sources

  1. Drugs.com: Wellbutrin SR: Package Insert / Prescribing Information.
  2. MedicalXpress: FDA pulls one generic form of wellbutrin off the market.
  3. ClinicalTrials.gov: Bioequivalence of Generic Bupropion Ver 1.02.
  4. Medical News Today: Wellbutrin: Side effects, dosage, alternatives, and more.
  5. Cognitive Market Research: Bupropion Hydrochloride Extended Release Tablets Market Report 2024 Edition.

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