Clinical trial NCT00126373: A Trial of Wellbutrin for Crohn's Disease
Official title: A Randomized Controlled Trial of Wellbutrin for Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Crohn Disease
Keywords: Crohn disease
TNF-alpha
Lead sponsor: Altschuler, Eric, M.D.
Sponsor class: INDIV
Collaborators: name: GlaxoSmithKline
First posted: 2005-08-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks
timeFrame: 0, 2, 4, 8, 12 weeks
Secondary outcomes:
measure: Number of patients with CDAI drop of at least 70 points at the end of twelve weeks
timeFrame: 0, 12 weeks
measure: Time course of CDAI
timeFrame: 0, 2, 4, 8, 12 weeks
measure: Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels
timeFrame: 0, 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
Study officials:
affiliation: Mt. Sinai Medical Center
name: Eric L Altschuler, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: