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A Randomized Controlled Trial of Wellbutrin for Crohn's Disease

Phase 2/Phase 3
18 Years
Not Enrolling
Crohn Disease

Thank you

Trial Information

A Randomized Controlled Trial of Wellbutrin for Crohn's Disease

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).

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

- 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

- Patients will be excluded if they are currently abusing alcohol or have alcohol

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

0, 2, 4, 8, 12 weeks

Safety Issue:


Principal Investigator

Eric L Altschuler, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mt. Sinai Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

March 2006

Related Keywords:

  • Crohn Disease
  • Crohn disease
  • TNF-alpha
  • Crohn Disease



University of Chicago Chicago, Illinois  60637
Mt. Sinai Medical Center New York, New York  10029