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Agomelatine and sertraline for the treatment of depression in type 2 diabetes mellitus

Agomelatine and sertraline for the treatment ofdepression in type 2 diabetes mellitus D. Karaiskos,1 E. Tzavellas,1 I. Ilias,2 I. Liappas,1 T. Paparrigopoulos1 Objective: The present study compared the efficacy of agomelatine and sertraline Fifteen per cent of patients with diabetes mellitus Psychiatry, Eginition Hospital,Athens, Greece in the treatment of symptoms of depression/anxiety, diabetes self-care and meta- (DM) meet the criteria for comorbid major bolic control in a sample of depressed patients with non-optimally controlled type depression. There is a linear relationship between depressive symptoms and poorer self-care, as well 2 diabetes mellitus (DM). Method: This was an observational open label study of as non-adherence to the management of DM. To 40 depressed patients with DM who were randomly assigned to receive either ag- omelatine or sertraline, and were assessed over a 4-month period for depression, diabetes, one should consider antidepressant anxiety, self-care, fasting plasma glucose, haemoglobin A1c and body weight.
Results: Lower anxiety and depression scores as well as higher self-care scores were measured in the agomelatine group compared with the sertraline group after Athens University MedicalSchool, 1st Department of 4 months of treatment. Although the main effects of treatment on final body Agomelatine possibly offers some advantages over weight and fasting plasma glucose were not significant, significantly lower final sertraline in the treatment of symptoms of depression and anxiety, as well as metabolic haemoglobin A1c levels were measured in the agomelatine group compared with parameters and health-related behaviours, in the sertraline group. Both antidepressants were well tolerated and none of the depressed patients with non-optimally controlled patients dropped-out of the study. Conclusion: The main finding of the present small pilot study was that agomelatine may be a promising agent in the treatmentof symptoms of depression and anxiety as well as in the improvement of health- related behaviours, in depressed patients with type 2 DM possibly offering some advantages over sertraline. However, the lack of a placebo control group limits thegeneralisability of the findings and warrants further studies.
modify the risk of developing a metabolic syndrome(13).
Approximately 15% of patients with diabetes mellitus Whether antidepressants also produce an antidia- (DM) meet the criteria for comorbid major depres- betic effect by promoting better self-care and meta- sion and a bidirectional relationship between the two bolic control still remains an unresolved issue (14).
conditions has been recently documented in large With this objective, the present study compared the prospective studies (1–7). Depression may play a role efficacy of agomelatine, a MT1/MT2 receptor mela- in the pathogenesis of DM in several ways: as a tonergic agonist and 5HT2C antagonist (15) and consequence of the same environmental stressors that sertraline, a serotonin reuptake inhibitor, in the influence glucose metabolism; as an independent treatment of symptoms of depression/anxiety, diabe- factor that also influences nutrition and lifestyle tes self-care and metabolic control in a sample of behaviours (8–10); as a phenotype for a range of depressed patients with non-optimally controlled stress-related disorders, which lead to overactivation There seems to be a linear relationship between depressive symptoms and poorer self-care (11); this also applies to subclinical depressive symptoms that This was an observational open label design study.
are associated with non-adherence to the manage- Participants were depressed patients with non-opti- ment of DM (12). Taking into consideration, the high mally controlled type 2 DM (with haemoglobin A1c; rates of diabetes in mentally ill patients, which signifi- A1C > 7.5%), aged 18–60 years, who were selected cantly impacts morbidity and mortality, effectively from a consecutive series of patients followed up at treating depression in this high-risk group could the outpatient unit of a primary care centre. All Int J Clin Pract, March 2013, 67, 3, 257–260. doi: 10.1111/ijcp.12112 Treatment of depression in diabetes mellitus patients were under standard treatment for diabetes made at several time points: for this study the initial by an endocrinologist and were referred to our hos- assessment (performed at the time of enrolment) and pital for psychiatric assessment and management.
the final assessment (performed 4 months after the Diagnosis of type 2 DM had been established accord- initial one) were taken into consideration.
ing to the WHO diabetes criteria, whereas diagnosisof mood disorder was based on the DSM-IV-TR criteria. Patients displaying active suicidal ideation, a All data were tested for normal distribution using history of any psychotic disorder, a serious physical the Kolmogorov–Smirnov test. For all reported val- disease or mental deterioration that would prevent ues, the mean and standard deviation (ÆSD) were them from being reliably interviewed, as well as those calculated. Analysis for HARS and HDRS scores, who were currently taking psychoactive medications, SCI-R scores, fasting plasma glucose, A1C and body were excluded from the study. Cognitive impairment, weight was carried out using analysis of covariance as assessed by a Mini Mental State Examination score (ANCOVA), examining the effect of treatment below 26, was an exclusion criterion.
(factor) on the parameters’ values at the last assess- Participants were assigned to two study groups: ment, covarying out the effect of each parameter’s the agomelatine group (n = 20), which included initial value; a Bonferroni correction was taken into patients treated with agomelatine (25–50 mg/day, consideration for multiple comparisons (18) Data mean dose: 31 Æ 11 mg/day), and the sertraline analysis was performed using MedCalc 10.2.0.0 group (n = 20), which included patients treated with (MedCalc, Mariakerke, Belgium) and SPSS v15 (SPSS, sertraline (50–100 mg/day; mean dose: 75 Æ 25 mg/ Written informed consent was obtained from the participants after detailed information on the studyobjectives and the research/therapeutic protocol was The mean age was 54.3 (Æ 12.5) years for the ago- provided. The study was carried out in accordance melatine group and 52.4 (Æ 11.4) for the sertraline with the Declaration of Helsinki and after the group. The two groups did not differ in terms of approval of the Scientific and Ethics Committee of family status (S: single, M: married, D: divorced, S: 3, M: 14, D: 3 for the agomelatine group and S: 1,M: 12, D: 7 for the sertraline group) and level of education (9.1 Æ 4.1 years for the the agomelatine Sociodemographic data (age, socioeconomic status, group and 9.6 Æ 3.6 for the sertraline group). Initial marital status, level of education) and detailed and final HARS and HDRS scores, SCI-R scores, medical history of all participants were recorded.
fasting plasma glucose, A1C and body weight are Symptoms of depression and anxiety were assessed presented in Table 1; there were no missing values.
using the Hamilton Depression Rating Scale (HDRS) The final HARS value was significantly related to and the Hamilton Anxiety Rating Scale (HARS); the initial HARS value (F1,37) = 5.447, p = 0.025).
these were considered the study’s primary outcomes The main effect of treatment on the last HARS value and all other parameters were secondary, exploratory was significant (F1,37 = 63.746, p < 0.001), with outcomes. The Self-Care Inventory (SCI-R) (16), a lower levels in the agomelatine group compared with 14-item self-report measure, was used to assess the the sertraline group. The final HDRS value was not sig- patients’ perception of the degree to which they adhere to treatment recommendations of self-care (F1,37) = 0.518, p = 0.476). The main effect of treat- for their DM. According to the SCI-R, self-care is ment on the last HDRS value was significant defined as the daily regimen tasks that the individual (F1,37 = 4.026, p = 0.050), with lower levels in the performs to manage diabetes. Adverse effects of agomelatine group compared with the sertraline group.
treatment were monitored using the Systematic The final SCI-R score was significantly related to Assessment for Treatment Emergent Events (SAF- the initial SCI-R score (F1,37 = 21.772, p < 0.001).
TEE) scale (17), which is a structured instrument for The main effect of treatment on the last SCI-R score recording adverse events, adapted for clinical studies.
was significant (F1,37 = 5.617, p = 0.023), with Fasting plasma glucose, A1C and body weight were higher levels in the agomelatine group compared with monitored at the first and last assessment. Also, the sertraline group. The final fasting plasma glucose detailed blood, thyroid and biochemistry tests were was significantly related to the initial fasting plasma obtained from all participants; liver function tests glucose (F1,37 = 25.786, p < 0.001). The main effect were performed in all patients at initiation and after of treatment on the final fasting plasma glucose was 6 weeks of treatment. Psychometric assessments were not significant (F1,37 = 0.158, p = 0.694). The final Int J Clin Pract, March 2013, 67, 3, 257–260 Treatment of depression in diabetes mellitus Table 1 Mean scores Æ SD of initial and final HARS and HDRS scores, SCI-R scores, fasting plasma glucose, A1C andbody weight HDRS, Hamilton Depression Rating Scale; HARS, Hamilton Anxiety Rating Scale; SCI-R, Self-Care Inventory.
A1C score was significantly related to the initial A1C DM self-care, which is negatively affected by depres- (F1,37 = 4.937, p = 0.032). The main effect of treat- sion and anxiety (19), significant improvement was ment on the final A1C was significant (F1,37 = 4.356, noted in both treatment groups, but it was greater in p = 0.044), with lower levels in the agomelatine group compared with the sertraline group. Final body administration, was not associated with body weight weight was significantly related to the initial body gain, which may also contribute to a better glycaemic weight (F1,37 = 70.891, p < 0.001). The main effect control and insulin sensitivity optimization (20).
of treatment on final body weight was not significant Both antidepressants were well-tolerated; side effects of both antidepressants were mild and none of the Both antidepressants were well tolerated and none participants dropped-out of the study.
of the patients dropped-out of the study. Treatment- There are relatively few controlled studies investi- related adverse events were recorded as follows in gating the efficacy of antidepressant treatment in the two groups: agomelatine/sertraline (n, %): nausea: DM patients, and these almost exclusively pertain to 0/5 (25%), dizziness: 2 (10%)/0, headache: 0/1 (5%), the use of SSRIs (21). SSRIs, and other novel antide- dry mouth: 0/2 (10%), diarrhoea: 0/4 (20%), insom- pressants as well, are better tolerated and safer for nia: 0/4 (20%), and somnolence: 5 (25%)/3 (15%).
use in diabetic patients with depression because theyhave less anticholinergic and antiadrenergic side effects, and lack quinidine-like action. A recentmeta-analysis of 11 randomised controlled studies The main finding of the present study was that ago- showed the efficacy of antidepressant treatment, the melatine may be a promising agent in the treatment combination of pharmacotherapy and psychotherapy of depression and, anxiety, as well as in the improve- being favourable both for depression and diabetes- ment of health-related behaviours, in depressed related parameters (21). A number of studies have patients with non-optimally controlled type 2 DM.
shown the significant antidepressant efficacy and the To our knowledge, this is the first study to investi- favourable side effect profile of agomelatine; our gate simultaneously the metabolic and mood effects study also suggests that agomelatine possibly offers of agomelatine in comparison with a selective seroto- some advantages over sertraline in the treatment of nin reuptake inhibitor (SSRI) drug in depressed symptoms of depression and anxiety, as well as meta- bolic parameters and health-related behaviours, in This study provides also some insight into the depressed patients with non-optimally controlled impact of treatment of depression on DM self-care, type 2 DM (22). Given that our study groups which is a crucial component of the long-term man- comprised of non-optimally controlled patients, our results highlight the need for early management of improvement in self-care with agomelatine is of depressive symptomatology in DM for improvement importance and warrants further studies. In terms of of treatment compliance and response.
Int J Clin Pract, March 2013, 67, 3, 257–260 Treatment of depression in diabetes mellitus The relatively small number of patients enrolled in this study and the relatively short follow-up, as wellas the lack of a placebo group, limit the generalis- ability of the findings and warrant further studies.
Furthermore, the patients included had suboptimal,but tolerable control of their DM; it needs to be assessed whether patients with worse control could fare differently with antidepressant treatment. Thehigh prevalence and chronicity of depression inpatients with DM and its adverse impact on func- tioning, quality of life and medical outcomes, high-lights the importance of evidence-based depression Concept/design DK & ET. Data analysis/interpreta- treatments. This study shows that agomelatine may tion TP & II. Drafting article DK & II. Critical revi- be opted for improving depression and self-care in sion of article TP & II. Approval of article IL.
Statistics II & DK. Data collection DK & ET.
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Relationship of depression to diabetes types 1 and action of agomelatine: synergy between melatoner- 2: epidemiology, biology, and treatment. Biol Psy- gic and 5-HT(2C) receptors. World J Biol Psychiatry Paper received October 2012, accepted December 2012 Int J Clin Pract, March 2013, 67, 3, 257–260

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