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Completed

NCT Number: NCT00126373

A Trial of Wellbutrin for Crohn's Disease

The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

Wellbutrin (bupropion) is approved for use as an antidepressant. There have been some cases in which people on Wellbutrin had significant improvement clinically in their Crohn's disease. In this trial, the hypothesis that Wellbutrin can induce clinical remission in Crohn's disease will be tested. The investigators will also be looking to see if Wellbutrin can lower levels of the inflammatory cytokine tumor necrosis factor-alpha (TNF).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate to severe Crohn's disease with 220 < CDAI < 400.
  • All patients in the study must have not had any anti-TNF antibodies for at least eight weeks.

Exclusion criteria

  • Patients will be excluded from the study if they have fulminant Crohn's disease requiring parenteral steroid treatment, hospitalization, or need of surgery imminently.
  • Patients with serious infections in the preceding three months, opportunistic infections within one month, or current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease will be excluded.
  • Patients will also be excluded from the study if they have a history of a seizure, epilepsy, presumed current central nervous system tumor, have or have had anorexia nervosa or bulimia, are currently taking or have taken in the last four weeks any drug in the monoamine oxidase inhibitor class, or are allergic to Wellbutrin.
  • Patients with active major depression or suicidal ideation will be excluded, as will patients with a score of 19 or higher on the Beck depression inventory.
  • Patients will be excluded if they are currently or have taken a medicine in the selective serotonin reuptake class, mirtazapine, venlafaxine, a tricyclic antidepressant, a mood stabilizing, or antipsychotic medication in the previous two weeks.
  • Patients will be excluded if they are currently abusing alcohol or have alcohol dependence.
  • Patients will be excluded from the study if their baseline liver function tests are greater than twice the upper limit of normal, or if a clinical investigator believes that their baseline chemistry, liver function tests or complete blood count contraindicates entry into the study.
  • Pregnant or lactating females are excluded.

Treatment and study plan

Wellbutrin (bupropion)

Drug

bupropion 150mg-300mg daily

Other names: Wellbutrin, bupropion

Primary outcomes

  1. Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks

    Time frame: 0, 2, 4, 8, 12 weeks

Secondary outcomes

  1. Number of patients with CDAI drop of at least 70 points at the end of twelve weeks

    Time frame: 0, 12 weeks

  2. Time course of CDAI

    Time frame: 0, 2, 4, 8, 12 weeks

  3. Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels

    Time frame: 0, 12 weeks

Sponsors and collaborators

Lead sponsor

Altschuler, Eric, M.D.

Indiv

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Randomized Controlled Trial of Wellbutrin for Crohn's Disease

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 4, 2005
Registry last updated
Jan 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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