Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease|
- Determination of steroid-induced mood changes. [ Time Frame: Participants will be followed up until they taper their steroid dose, average of 6 weeks ] [ Designated as safety issue: Yes ]Incidence rate of steroid-induced mood changes (as defined by BDI-II score increase by 10 points, or manic/hypomanic symptoms with ISS activation score increase by 50 points) will be determined. The score from validated scales will be analyzed using t-test to determine if there is any statistically significant change from baseline after institution of steroid treatment. Total scores as well as modified scale scores (after removing gastrointestinal symptoms that may be influenced by IBD activities) will be compared. Descriptive analyses will also be performed.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Participants who are started on Prednisone 40 mg per day for 2 weeks and then tapered.
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.
Other Name: Prednisone 40 mg
Patients who are eligible to participate in the study are invited. Before starting prednisone therapy, the following data are collected: basic demographic data (age, gender), education history, past medical history (particularly IBD history such as age of diagnosis and previous treatments/surgery), current medications/non-prescription drugs will be collected. IBD activity is measured by Harvey-Bradshaw Index for Crohn's Disease and Simple Clinical Colitis Activity Index (SCCAI) for all subjects with Ulcerative Colitis. Subjects are asked to complete self-administered surveys --- Internal State Scale (ISS) for patients to self-report mood states including depressive, manic, or mixed states and Beck Depression Inventory II (BDI-II) for screening depression
Two weeks after starting Prednisone 40 mg/day and at the end of steroid taper, IBD activity will be measured by Harvey-Bradshaw Index for Crohn's Disease and Simple Clinical Colitis Activity Index (SCCAI) for all subjects with Ulcerative Colitis. Self-administered surveys --- Internal State Scale (ISS) and Beck Depression Inventory II (BDI-II) are completed.
It is possible that a new diagnosis of an underlying psychiatric disorder may be discovered as a result of participating in this study. In the event that an underlying psychiatric disorder is suspected based on the results of the questionnaires on the first visit (BDI-II ≥21 moderate depression or ISS Activation scale ≥ 155), the patient would be offered the option for an expedited formal psychiatric referral. This will not exclude them from the study unless therapy is deemed necessary by the consulting psychiatrist.
Should patients develop significant mood changes impairing daily/social functioning during the study as a result of steroid therapy, they will be assessed urgently by attending gastroenterologist and if necessary, in consultation with a psychiatrist to determine the best course of action, which may include cessation of steroid therapy or addition of psychiatric therapy. Otherwise, less significant mood changes will be monitored closely as these may be expected to resolve upon discontinuation of steroid therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01981889
|Contact: Cherry E Galorport||604-688-6332 ext email@example.com|
|Canada, British Columbia|
|Pacific Gastroenterology Associates||Recruiting|
|Vancouver, British Columbia, Canada, V6Z 2K5|
|Contact: Cherry E Galorport 604-688-6332 ext 222 firstname.lastname@example.org|
|Principal Investigator: Greg Rosenfeld, MD|
|Sub-Investigator: Brian Bressler, MD|
|Sub-Investigator: George Ou, MD|
|Principal Investigator:||Greg Rosenfeld, MD||University of British Columbia|