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

OBJECTIVE: The present study compared the efficacy of agomelatine and sertraline in the treatment of symptoms of depression/anxiety, diabetes self-care and metabolic control in a sample of depressed patients with non-optimally controlled type 2 diabetes mellitus (DM). METHOD: This was an observational open label study of 40 depressed patients with DM who were randomly assigned to receive either agomelatine or sertraline, and were assessed over a 4-month period for depression, 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 4 months of treatment. Although the main effects of treatment on final body weight and fasting plasma glucose were not significant, significantly lower final haemoglobin A1c levels were measured in the agomelatine group compared with the sertraline group. Both antidepressants were well tolerated and none of the 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 treatment of 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 the generalisability of the findings and warrants further studies.

Stress, coping strategies and social support in patients with primary Sjögren's syndrome prior to disease onset: a retrospective case-control study.

OBJECTIVES: Previous evidence suggests the role of psychological stress in triggering the onset of autoimmunity. We aimed to investigate whether stress following major and minor life events could precede the onset of primary Sjögren's syndrome (pSS). The role of coping strategies and social support, as compensating buffering mechanisms, was also explored. METHODS: 47 patients with pSS were compared with two control groups: 35 patients with lymphoma (disease controls, DC) and 120 healthy controls (HC) with disease onset within the previous year. All subjects completed questionnaires assessing the occurrence of major and minor stressful events, coping strategies and social support prior to disease onset. Data analysis was performed by univariate and multivariate logistic regression models. RESULTS: A higher number of patients with pSS reported the occurrence of negative stressful life events prior to disease onset compared with patients with lymphoma and HC, while the number and impact of daily hassles did not differ between the three groups. Coping strategies were defective and the overall social support was lower in patients with pSS compared with DC and HC groups. In the multivariate model, pSS status was associated with maladaptive coping and lower overall social support relative to DC and HC, as well as with an increased number of negative stressful life events compared with HC but not DC. CONCLUSIONS: Prior to disease onset, patients with pSS experience high psychological stress following major negative life events, without developing satisfactory adaptive coping strategies to confront their stressful life changes. Lack of social support may contribute to the relative risk of disease development.

Agomelatine augmentation in obsessive compulsive disorder: a preliminary report.

Obsessive-compulsive disorder (OCD) is often the anxiety disorder that affects approximately 2% of the population. This disorder is associated with significant morbidity and dysfunction, and is included in the World Health Organization list of the ten most disabling medical illnesses. The therapeutic response of patients with OCD is relatively poor compared with that of other mental disorders. Pharmacological interventions for OCD have focused on modulating primarily serotonin function and secondarily dopamine neurotransmission. Augmentation treatment has been the subject of several studies in treatment-resistant obsessive compulsive disorder (OCD). We hypothesized that medications with a dual action on the melatoninergic and serotoninergic systems may be of use in treatment-resistant OCD. In this open label study we investigated the efficacy and safety of agomelatine augmentation in treatment-resistant OCD. Twelve patients, aged 18-50, fulfilling OCD criteria, having failed to respond to adequate treatment with a Serotonine Reuptake Inhibitor for at least 16 weeks, were assigned to receive agomelatine augmentation. Subjects were assessed with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), and were screened for treatment-emergent side effects at baseline and week 16 of treatment. We excluded patients with comorbid psychopathology, serious medical comorbidity, current or past history of substance abuse and severe personality disorders as well as patients receiving psychotherapy in addition to psychopharmacological treatment. Agomelatine augmentation lead to net improvement in Y-BOCS and its obsession and compulsion subscales after 16 weeks of treatment (all p<0.005). Agomelatine augmentation was well-tolerated and none of the patients dropped-out. Treatment-related adverse events were recorded as follows: (n, %): nausea: 1 (8.3%), headache 4 (33.3%), dizziness: 3 (25%) and somnolence: 2 (16.7%). The present case series study has several limitations due to its open-label design and the absence of a placebo or active control group. The small number of patients further limits the impact of our findings. The present case series study showed that a 16 week add-on treatment with agomelatine, achieved on average a 25% improvement in Y-BOCS in refractory to treatment OCD patients; side effects were mild, and none of the patients dropped out throughout the 16-week study period. Agomelatine could be efficacious and well tolerated as an augmenting agent in refractory to treatment OCD. The unique pharmacological profile of agomelatine and its dual action on serotoninergic and melatoninergic receptors may be of interest in this difficult-to-treat illness. Further controlled studies are warranted to explore the efficacy of agomelatine, as well as the potential role of circadian rhythm modulation both in the pathophysiology and treatment of OCD.

Glandular cystitis and lithium intoxication in a patient with bipolar disorder.

A 42-year-old woman, with a 12-year history of bipolar disorder was referred to our department due to tremor, sedation, dysarthria, polyuria and polydipsia. She had been on lithium monotherapy during the last 3 years. On admission, her cognitive status was intact, and neither depression nor euphoria was reported. Lithium plasma levels were 1.6 mEq/L, whereas creatinine and urea levels were 2.8 IU/L and 110 IU/L, respectively. The patient did not take other medications or misused lithium. Lithium was immediately discontinued. Ultrasound scans of the urinary tract were suggestive of bilateral hydronephrosis secondary to bladder contraction and cystoscopy-guided bladder biopsy revealed glandular cystitis a benign tumour into the bladder's wall, which impeded the bladder's contraction leading to hydronephrosis and subsequent toxic lithium plasma levels. The patient was switched to valproate and was referred for surgical excision of the lesion. One year later, she was in good physical and mental health under treatment with valproate (1000 mg/day). This is the first case report of glandular cystitis leading to lithium intoxication by impairing renal function. Acute renal failure leading to lithium intoxication would be possible. However, a thorough imaging, endoscopical and histological study revealed glandular cystitis as the cause of renal impairment. Although physicians are alert about lithium's toxicity and a monitoring of renal function is routinely prescribed, little focus has been made on the integrity of the urinary tract. We suggest that urinary tract imaging should be part of the routine work-up in patients presenting with symptoms and signs of lithium intoxication, since concomitant urinary tract lesions might occasionally be the cause of renal impairment leading to reduced lithium excretion.

[The spectrum of Tourette Syndrome and difficulties in differential diagnosis: a case report].

Tourette syndrome (TS) is a neurodevelopmental disorder characterized by early onset motor and vocal tics. TS should be differentiated from various movement disorders. We report the case of a 21 year-old-man who was admitted to our clinic due to treatment resistant cervical dystonia attributed to neuroleptics. During the last five years he had been treated for depressed mood, somatic delusions and aggressive behaviour. He had been given SSRIs and atypical antipsychotics at low doses; six months prior to his admission he had been switched to risperidone. Clinical examination revealed torticollis, motor stereotypies, vocal tics (sniffing, repetition of words), mental koprolalia and obsessive-compulsive symptoms. He complained of repetitive intrusive thoughts of harming his sister and thoughts of a "delusional" nature regarding somatic complaints. The patient was diagnosed as TS and was successfully treated accordingly. The presented case illustrates that TS can mimic other movement disorders. Whether patients with TS are at higher risk of developing dystonia, or tics and dystonia share a common pathophysiological mechanism (dopamine-inhibiting processes are probably involved in both conditions) is still debatable.

An open pilot study of tiagabine in alcohol dependence: tolerability and clinical effects.

There is evidence that GABAergic anticonvulsants can be efficacious in the treatment of alcohol dependence and in the prevention of alcohol relapse because these agents act on the substrate that is involved in alcoholism. Tiagabine, a selective GABA transporter1 reuptake inhibitor, may be a promising candidate for the treatment of alcohol-dependent individuals. In this randomized, open pilot study, we aimed to investigate the efficacy and tolerability of tiagabine as adjunctive treatment of alcohol-dependent individuals (N = 60) during the immediate post-detoxification period and during a 6-month follow-up period following alcohol withdrawal. A control non-medicated group of alcohol-dependent individuals (N = 60) was used for comparisons in terms of anxiety and depressive symptoms, craving and drinking outcome. Although a steady improvement in terms of psychopathology, craving and global functioning was observed in both groups throughout the study, subjects on tiagabine improved significantly more compared to the control subjects (P < 0.001). Furthermore, the relapse rate in the tiagabine group was lower than in the control group (7 vs 14.3%). Tiagabine was well tolerated and only a minority of the participants reported some adverse effects in the beginning of tiagabine treatment. Results from this study suggest that tiagabine is a safe and effective medication for the management of alcohol dependence when given adjunctively to a standard psychotherapy treatment. Further studies are warranted before definite conclusions can be reached.