Sertraline for Prevention of Depression Recurrence in Diabetes Mellitus

Lustman, Patrick J.; Clouse, Ray E.; Nix, Billy D.; Freedland, Kenneth E.; Rubin, Eugene H.; McGill, Janet B.; Williams, Monique; Gelenberg, Alan J.; Ciechanowski, Paul; Hirsch, Irl B.

doi:10.1001/archpsyc.63.5.521

Cited by 183 publications

(124 citation statements)

References 76 publications

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“…Both psychiatric medication [10-12] and psychological interventions [13-16] have been proven to be efficient in alleviating depression in diabetic patients. However, the effects of pharmacological treatment of depression on glycaemic control remain unclear, with some trials pointing to adverse effects, and some reporting on modest positive effects on HbA 1c values.…”

Section: Introductionmentioning

confidence: 99%

Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual

Pibernik-Okanović

Ajduković

Lovrenčić

et al. 2011

Trials

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BackgroundThe prevalence of mood difficulties in persons with diabetes is approximately twice that in the general population, affecting the health outcomes and patients' quality of life in an undesirable way. Although subsyndromal depression is an important predictor of a more serious clinical depression, it is often overlooked. This study aims to compare the effects of two non-pharmacological interventions for subsyndromal depression, psychoeducation and physical exercise, with diabetes treatment as usual on mood- and diabetes-related outcomes.Methods and DesignType 2 diabetic patients aged 18-65 yrs. who report mood difficulties and the related need for help in a mail survey will be potential participants. After giving informed consent, they will be randomly assigned to one of the three groups (psychoeducation, physical activity, treatment as usual). Depressive symptoms, diabetes distress, health-related quality of life and diabetes self-care activities will be assessed at baseline, at 6 weeks, 6 months and 12 months. A structured clinical interview for DSM-IV Axis I Disorders (SCID-I) will be performed at baseline and at one-year follow-up in order to determine the clinical significance of the patients' depressive symptoms. Disease-related data will be collected from patients' files and from additional physical examinations and laboratory tests.The two interventions will be comparable in terms of format (small group work), duration (six sessions) and approach (interactive learning; supporting the participants' active roles). The group treated as usual will be informed about their screening results and about the importance of treating depression. They will be provided with brief re-education on diabetes and written self-help instructions to cope with mood difficulties.Primary outcomes will be depressive symptoms. Secondary outcomes will be glycaemic control, diabetes-related distress, self-management of diabetes and health-related quality of life. Tertiary outcomes will be biochemical markers reflecting common pathophysiological processes of insulin resistance, inflammation and oxidative damage that are assumed to be intertwined in both diabetes and depression. The mixed-effect linear model will be used to compare the outcome variables.Power analysis has indicated that the two intervention groups and the control group should comprise 59 patients to enable detection of clinically meaningful differences in depressive symptoms with a power of 80% and alpha = 0.05. Outcomes will be analysed on an intention-to-treat basis.Trial RegistrationISRCTN: ISRCTN05673017

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Section: Introductionmentioning

confidence: 99%

Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual

Pibernik-Okanović

Ajduković

Lovrenčić

et al. 2011

Trials

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“…This is not surprising, as the elderly remain underrepresented in depression treatment trials (13). When adults of all ages with diabetes are studied together, depression responds acutely to pharmacotherapy and psychotherapy (14 -17), with depression management resulting in amelioration of both mood and glycemic control (9, 15,16). These effects are often transient, as depression in diabetes appears to be highly recurrent (18,19).…”

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confidence: 99%

“…Maintenance antidepressant trials in general psychiatric populations (without diabetes) demonstrate the efficacy of antidepressants in prolonging the depression-free interval, decreasing depression recurrence rates by ϳ30% over 3 years (16,(21)(22)(23)(24)(25)(26). Similar data in older subjects are limited, and results are inconclusive (27)(28)(29).…”

mentioning

confidence: 99%

“…Similar data in older subjects are limited, and results are inconclusive (27)(28)(29). We recently conducted a double-blind, placebo-controlled, multicenter, two-phase clinical trial of sertraline for treatment of depression in patients aged 18 -76 years with comorbid diabetes and depression (16). In the induction phase, patients with major depressive disorder (MDD) received 16 weeks of open-label treatment with sertraline.…”

mentioning

confidence: 99%

“…We recently conducted a double-blind, placebo-controlled, multicenter, two-phase clinical trial of sertraline for treatment of depression in patients aged 18 -76 years with comorbid diabetes and depression (16). In the induction phase, patients with major depressive disorder (MDD) received 16 weeks of open-label treatment with sertraline. In the subsequent maintenance phase, participants who achieved depression recovery on sertraline were randomized to sertraline or placebo for 52 weeks or until depression recurred.…”

mentioning

confidence: 99%

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Efficacy of Sertraline in Prevention of Depression Recurrence in Older Versus Younger Adults With Diabetes

et al. 2007

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OBJECTIVE -Sertraline maintenance therapy effectively delays recurrence of major depressive disorder in adult diabetic patients when data are examined across all age-groups. A secondary analysis was performed to assess this effect in younger and older subsets of patients.RESEARCH DESIGN AND METHODS -Younger (aged Ͻ55 years, n ϭ 85) and older (aged Ն55 years, n ϭ 67) subsets were identified from a multicenter, double-blind, placebocontrolled, maintenance treatment trial of sertraline in diabetic participants who achieved depression recovery with open-label sertraline treatment. Cox proportional hazards models were used to determine differences in time to depression recurrence between treatment arms (sertraline or placebo) for each age subset and between age subsets for each treatment.RESULTS -In younger subjects, sertraline conferred significantly greater prophylaxis against depression recurrence than placebo (hazard ratio 0.37 [95% CI 0.20 -0.71]; P ϭ 0.003). Benefits of sertraline maintenance therapy were lost in older participants (0.94 [0.39 -2.29]; P ϭ 0.89). There was no difference in time to recurrence for sertraline-treated subjects between age subsets (P ϭ 0.65), but older subjects had a significantly longer time to recurrence on placebo than younger subjects (P ϭ 0.03).CONCLUSIONS -While sertraline significantly increased the time to depression recurrence in the younger diabetic participants, there was no treatment effect in those aged Ն55 years because of a high placebo response rate. Further research is necessary to determine the mechanisms responsible for this effect and whether depression maintenance strategies specific for older patients with diabetes should be developed. Diabetes Care 30:801-806, 2007

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Psychological and pharmacological interventions for depression in patients with diabetes mellitus and depression

Baumeister

Hutter

Bengel

2012

Cochrane Database of Systematic Reviews

129

127

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Sertraline for Prevention of Depression Recurrence in Diabetes Mellitus

Cited by 183 publications

References 76 publications

Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual

Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual

Efficacy of Sertraline in Prevention of Depression Recurrence in Older Versus Younger Adults With Diabetes

Psychological and pharmacological interventions for depression in patients with diabetes mellitus and depression

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