CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 53 enrolled
Drug / intervention
Prednisonedrug
Likely dose
Prednisone 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01981889
NCT01981889Phase 4Completed
CompareCT.gov

Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease

University of British Columbia·interventional·Posted Nov 13, 2013·Updated Nov 2, 2016

In Brief

A Phase 4 clinical trial evaluating Prednisone for Inflammatory Bowel Disease 11. Completed, enrolled 53 participants across 1 site.

Detailed Summary

Steroid is commonly used to treat autoimmune disorders such as rheumatoid arthritis, lupus, and inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis). However, its use is associated with numerous systemic side-effects, including diabetes, osteoporosis, and potentially significant mood changes. The investigators wish to determine how common patients with inflammatory bowel disease experience mood changes when they take steroid for their disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Disease 11
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartOct 1, 2013
Primary CompletionMay 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.6 years ago

Interventions

Prednisonedrug

Participants will be started on oral prednisone 40mg/day for two weeks as per standard of practice in IBD management, before starting a tapering course.