Amitriptyline for Crohn's Disease

(AIMS-CD Trial)

Overseen By Charlie Bourque Jr.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Tricyclics, MAOIs, Cisapride, others

Disqualifiers: Active Crohn's, Cardiac issues, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

Many individuals with Crohn's disease continue to experience abdominal pain, bloating, or bowel habit changes even when their inflammation is controlled. Amitriptyline is a medication commonly used at low doses to treat irritable bowel syndrome (IBS) and abdominal pain. This study will assess whether amitriptyline is safe and reduces those ongoing GI symptoms in adults with Crohn's disease in remission.

Who Is on the Research Team?

Allen A. Lee, MD, MS

Principal Investigator

University of Michigan

Prashant Singh, MD

Principal Investigator

University of Michigan

Shrinivas Bishu, MD

Principal Investigator

University of Michigan

Kinza Tareen, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with Crohn's disease by my doctor.

Completion of a 12-lead electrocardiogram (ECG) within previous 12 months or at baseline demonstrating specific conduction parameters

My Crohn's disease has been in remission for the past 3 months.

Exclusion Criteria

I have active Crohn's disease or recent severe flare-ups.

Psychiatric/neurologic exclusions such as active major depressive disorder, history of severe psychiatric conditions, or recent suicidal ideation

Any condition that, in the investigator's opinion, would interfere with the study or pose undue risks to the participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either amitriptyline or placebo to assess safety and symptom reduction

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amitriptyline

How Is the Trial Designed?

Group I: Amitriptyline Experimental Treatment 1 Intervention

Roughly 50 participants

Group II: Placebo Placebo Group 1 Intervention

Roughly 50 participants

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+