A Trial of Wellbutrin for Crohn's Disease

Crohn Disease Clinical Trial

Official title:

A Randomized Controlled Trial of Wellbutrin for Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126373
• Other study ID #: CGO10410022
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 2, 2005
• Last updated: January 19, 2012
• Start date: May 2005
• Est. completion date: March 2006

Study information

• Verified date: January 2012
• Source: Altschuler, Eric, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Wellbutrin (bupropion)
bupropion 150mg-300mg daily

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Mt. Sinai Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Altschuler, Eric, M.D.	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks		0, 2, 4, 8, 12 weeks	No
Secondary	Number of patients with CDAI drop of at least 70 points at the end of twelve weeks		0, 12 weeks	No
Secondary	Time course of CDAI		0, 2, 4, 8, 12 weeks	No
Secondary	Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels		0, 12 weeks	No