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Research Transfer > System-Linked Research Unit Working Paper Series #97-14
   

97-14

System-Linked Research Unit
Working Paper Series #97-14

ZOLOFT 6 MONTH FOLLOW-UP: A RANDOMIZED TRIAL OF THE EFFECTS AND EXPENSE OF ZOLOFT (SERTRALINE) VS INTERPERSONAL PSYCHOTHERAPY, ALONE OR IN COMBINATION FOR PEOPLE WITH DYSTHYMIA IN PRIMARY CARE

Browne G, Steiner M, Roberts J, Gafni A, Byrne C, Dunn E, Jamieson E, Webb M, Bell B, Mills M, Chalklin L, Wallik D, Kramer J

ABSTRACT

Rostered patients in a Health Service Organization in southern Ontario, as well as persons recruited from the region, were screened by phone for 9 psychiatric disorders (major depressive disorder, dysthymia, generalized anxiety disorder, panic, social phobia, simple phobia, agoraphobia,alcohol and drug dependence) using the UM-CIDI short form. Those who scored positive on any disorder were invited to see a health care provider, those who consented to the visit were screened for dysthymia and/or major depressive disorder using a modified SCID-NP. Those who were positive for dysthymia and consented to participate were randomized to one of three treatment groups: sertraline alone; IPT alone; or sertraline in combination with IPT. Patients have follow-up clinic visits at 3 and 6 weeks, and at 3,6,9,12,15,18,21 and 24 months. Blind assessment of outcome are made by trained interviewers at baseline, and at 6,12 and 24 months using the Montgomery-Asberg Depression Rating Scale (MADRS). Of the 5,873 persons screened, 2,536 were positive on at least one of the 9 disorders; and of those positive, 1,544 consented to the visit of which 736 were positive for dysthymia and of those, 29 refused to participate. Altogether, 707 dysthymic patients were randomized: 229 to sertraline alone; 231 to IPT alone; and 247 to sertraline in combination with IPT. Sertraline was prescribed by the attending physician at an initial dose of 25mg/day with the option to increase it gradually up to a maximum of 200 mg/day. Sertraline plasma levels are measured both at regular and random visits. IPT was provided by trained staff; a total of up to 16 sessions were provided within the first three months of the study. This is an ongoing study.

Preliminary results comparing the responses in each of the three treatment groups at the 6 month follow-up visit indicate that Sertraline alone, is easier to comply with than IPT alone, as effective as Sertraline plus IPT, more effective than IPT alone and no more expensive from a societal point of view. We await the two year follow-up to assess the Back to Topenduring nature of these comparative effects and expenses.

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