Abstract |
Several studies have shown that 20 to 66.2% of patients with rheumatoid arthritis have associated psychiatric comorbidity especially depression. Dothiepin hydrochloride is a well-established and effective antidepressant in patients with depressive symptoms of varying severity and co-existing anxiety. To document the efficacy and tolerability of dothiepin hydrochloride in the management of major depressive disorder (MDD) in rheumatoid arthritis patients a phase IV, open, single arm, prospective study was initiated with dothiepin hydrochloride in the dose of 75 mg/day, duration of therapy was 6 weeks. Twenty-five rheumatoid arthritis patients suffering from co-morbid MDD completed the 6-week dothiepin hydrochoride treatment and were considered for final analysis. There was significant reduction (p < 0.05) in mean HAM-D scores at week 2 (13.92 +/- 5.45), week 4 (9.28 +/- 4.13) and week 6 (5.72 +/- 3.26) compared to baseline (21.64 +/- 5.93). There was significant reduction (p < 0.05) in mean HAM-A scores at week 2 (6.52 +/- 3.34), week 4 (4.0 +/- 2.25) and week 6 (2.76 +/- 1.59) compared to baseline (10.68 +/- 3.68). The global impression of efficacy at the end of 6 weeks of dothiepin hydrochloride treatment was rated by the clinician (psychiatrist) as marked and moderate improvement in 20 (80%) and 5 patients (20%) respectively. Only 2 patients reported dry mouth as an adverse event in the study. The overall assessment of tolerability at the end of 6 weeks of dothiepin hydrochloride treatment was rated by the clinician (psychiatrist) as good and fair in 19 (76%) and 6 patients (24%) respectively. Dothiepin hydrochloride was found to be an effective and well-tolerated drug in the management of MDD and anxiety in patients suffering from rheumatoid arthritis.
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Authors | H S Dhavale, Sushil Gawande, Vinaya Bhagat, Vijay Durge, Vikram Londhe, Seema Kini, M Y Nadkar, N E Borges |
Journal | Journal of the Indian Medical Association
(J Indian Med Assoc)
Vol. 103
Issue 5
Pg. 291-4
(May 2005)
ISSN: 0019-5847 [Print] India |
PMID | 16229336
(Publication Type: Clinical Trial, Clinical Trial, Phase IV, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adolescent
- Adult
- Aged
- Arthritis, Rheumatoid
(complications, diagnosis, psychology)
- Depressive Disorder
(diagnosis, drug therapy, etiology)
- Developing Countries
- Dose-Response Relationship, Drug
- Dothiepin
(administration & dosage)
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- India
- Male
- Maximum Tolerated Dose
- Middle Aged
- Patient Satisfaction
- Prospective Studies
- Risk Assessment
- Severity of Illness Index
- Single-Blind Method
- Treatment Outcome
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