A Trial of Wellbutrin for Crohn's Disease

Last updated: January 19, 2012
Sponsor: Altschuler, Eric, M.D.
Overall Status: Completed

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00126373
CGO10410022
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 eightweeks.

Exclusion

Exclusion Criteria:

  • Patients will be excluded from the study if they have fulminant Crohn's diseaserequiring parenteral steroid treatment, hospitalization, or need of surgeryimminently.

  • Patients with serious infections in the preceding three months, opportunisticinfections within one month, or current signs or symptoms of severe, progressive oruncontrolled 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 anorexianervosa or bulimia, are currently taking or have taken in the last four weeks any drugin the monoamine oxidase inhibitor class, or are allergic to Wellbutrin.

  • Patients with active major depression or suicidal ideation will be excluded, as willpatients 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 theselective serotonin reuptake class, mirtazapine, venlafaxine, a tricyclicantidepressant, a mood stabilizing, or antipsychotic medication in the previous twoweeks.

  • Patients will be excluded if they are currently abusing alcohol or have alcoholdependence.

  • Patients will be excluded from the study if their baseline liver function tests aregreater than twice the upper limit of normal, or if a clinical investigator believesthat their baseline chemistry, liver function tests or complete blood countcontraindicates entry into the study.

  • Pregnant or lactating females are excluded.

Study Design

Total Participants: 1
Study Start date:
May 01, 2005
Estimated Completion Date:
March 31, 2006

Study Description

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).

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Mt. Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

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