title: Evaluation of efficacy and tolerability of dothiepin hydrochloride in the management of major depression in patients suffering from rheumatoid arthritis.
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.
authors.affiliation: TNMC & BYL Nair Charitable Hospital, Dr AL Nair Road, Mumbai 400008.
authors.forename: H S
authors.initials: HS
authors.lastname: Dhavale
authors.forename: Sushil
authors.initials: S
authors.lastname: Gawande
authors.forename: Vinaya
authors.initials: V
authors.lastname: Bhagat
authors.forename: Vijay
authors.initials: V
authors.lastname: Durge
authors.forename: Vikram
authors.initials: V
authors.lastname: Londhe
authors.forename: Seema
authors.initials: S
authors.lastname: Kini
authors.forename: M Y
authors.initials: MY
authors.lastname: Nadkar
authors.forename: N E
authors.initials: NE
authors.lastname: Borges
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000175:diagnosis / Q000523:psychology*; D003866:Depressive Disorder / Q000175:diagnosis* / Q000188:drug therapy* / Q000209:etiology; D003906:Developing Countries; D004305:Dose-Response Relationship, Drug; D004308:Dothiepin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007194:India; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D004308:Dothiepin