drugset / Trial / NCT01981889
Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease
NaSingle-groupOpen-label
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.
Timeline
- Start
- 2013-10
- Primary completion
- 2016-05
- Completion
- 2016-08
Publications
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- Background Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23; quiz 524. doi: 10.1038/ajg.2009.727. Epub 2010 Jan 12.
- Background Lewis DA, Smith RE. Steroid-induced psychiatric syndromes. A report of 14 cases and a review of the literature. J Affect Disord. 1983 Nov;5(4):319-32. doi: 10.1016/0165-0327(83)90022-8.
- Background Fardet L, Flahault A, Kettaneh A, Tiev KP, Genereau T, Toledano C, Lebbe C, Cabane J. Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion. Br J Dermatol. 2007 Jul;157(1):142-8. doi: 10.1111/j.1365-2133.2007.07950.x. Epub 2007 May 14.
- Background Naber D, Sand P, Heigl B. Psychopathological and neuropsychological effects of 8-days' corticosteroid treatment. A prospective study. Psychoneuroendocrinology. 1996 Jan;21(1):25-31. doi: 10.1016/0306-4530(95)00031-3.
- Background Brown ES, Suppes T, Khan DA, Carmody TJ 3rd. Mood changes during prednisone bursts in outpatients with asthma. J Clin Psychopharmacol. 2002 Feb;22(1):55-61. doi: 10.1097/00004714-200202000-00009.
- Background Bolanos SH, Khan DA, Hanczyc M, Bauer MS, Dhanani N, Brown ES. Assessment of mood states in patients receiving long-term corticosteroid therapy and in controls with patient-rated and clinician-rated scales. Ann Allergy Asthma Immunol. 2004 May;92(5):500-5. doi: 10.1016/S1081-1206(10)61756-5.
- Background Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
- Background Bauer MS, Vojta C, Kinosian B, Altshuler L, Glick H. The Internal State Scale: replication of its discriminating abilities in a multisite, public sector sample. Bipolar Disord. 2000 Dec;2(4):340-6. doi: 10.1034/j.1399-5618.2000.020409.x.
- Background Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available.
- Background Walmsley RS, Ayres RC, Pounder RE, Allan RN. A simple clinical colitis activity index. Gut. 1998 Jul;43(1):29-32. doi: 10.1136/gut.43.1.29.
- Results Bhangle SD, Kramer N, Rosenstein ED. Corticosteroid-induced neuropsychiatric disorders: review and contrast with neuropsychiatric lupus. Rheumatol Int. 2013 Aug;33(8):1923-32. doi: 10.1007/s00296-013-2750-z. Epub 2013 Apr 16.
- Results Brown ES, Chamberlain W, Dhanani N, Paranjpe P, Carmody TJ, Sargeant M. An open-label trial of olanzapine for corticosteroid-induced mood symptoms. J Affect Disord. 2004 Dec;83(2-3):277-81. doi: 10.1016/j.jad.2004.07.001.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisone | Other / unclassified | 40 mg | Oral |