Quetiapine extended-release (Seroquel-XR) versus amitriptyline monotherapy for treating patients with fibromyalgia: a 16-week, randomized, flexible-dose, open-label trial.

RATIONALE: Previous open-label studies have suggested that quetiapine could be a valuable alternative for treating fibromyalgia. OBJECTIVE: This study aims to compare the efficacy and tolerability of extended-release quetiapine with amitriptyline for treating fibromyalgia. METHODS: This study was a randomized, open-label, flexible-dose, non-inferiority trial. Patients with fibromyalgia were randomized to receive quetiapine extended-release (XR) (N = 45) (50 to 300 mg daily) or amitriptyline (N = 45) (10 to 75 mg daily) for 16 weeks. The primary endpoint was the change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score; the non-inferiority threshold was established at 8 points. The secondary outcomes included sleep quality, anxiety, depression, and quality of life. RESULTS: Twenty-two (49%) patients in the quetiapine group and 34 (76%) patients in the amitriptyline group completed the study. We found a reduction of 9.8 points in the total FIQ score at the endpoint for the quetiapine-treated patients compared to 13.9 points for the amitriptyline-treated patients, for a difference of 4.14 points (80% confidence interval (CI) -0.70 to 8.98). No significant differences were found between the quetiapine XR and amitriptyline groups for any of the secondary outcomes. The proportion of patients discontinuing treatment due to adverse events was higher in the quetiapine group (n = 14, 31.1%) than the amitriptyline group (n = 3, 6.6%). CONCLUSIONS: Our results appear to indicate that quetiapine XR does not provide similar efficacy to amitriptyline for treating patients with fibromyalgia. Quetiapine XR had a worse tolerability than amitriptyline in this population, possibly due to a relatively high starting dose.

Treatment patterns in major depressive disorder after an inadequate response to first-line antidepressant treatment.

BACKGROUND: The aim of the study was to determine the most common pharmacological strategies used in the management of major depressive disorder (MDD) after an inadequate response to first-line antidepressant treatment in clinical practice. METHODS: Multicenter, non-interventional study in adult outpatients with a DSM-IV-TR diagnosis of MDD and inadequate response to first-line antidepressant medication. Multiple logistic regression analyses were performed to identify independent factors associated with the adoption of a specific second-line strategy. RESULTS: A total of 273 patients were analyzed (mean age: 46.8 years, 67.8% female). Baseline mean Montgomery-Asberg Depression Rating Scale total score was 32.1 (95%CI 31.2-32.9). The most common strategies were: switching antidepressant medication (39.6%), augmentation (18.8%), and combination therapy (17.9%). Atypical antipsychotic drugs were the most commonly used agent for augmenting antidepressant effect. The presence of psychotic symptoms and the number of previous major depressive episodes were associated with the adoption of augmenting strategy (OR = 3.2 and 1.2, respectively). CONCLUSION: The switch to another antidepressant agent was the most common second-line therapeutic approach. Psychiatrists chose augmentation based on a worse patients' clinical profile (number of previous episodes and presence of psychotic symptoms).

Number of prior episodes and the presence of depressive symptoms are associated with longer length of stay for patients with acute manic episodes.

BACKGROUND: Few studies have analyzed predictors of length of stay (LOS) in patients admitted due to acute bipolar manic episodes. The purpose of the present study was to estimate LOS and to determine the potential sociodemographic and clinical risk factors associated with a longer hospitalization. Such information could be useful to identify those patients at high risk for long LOS and to allocate them to special treatments, with the aim of optimizing their hospital management. METHODS: This was a cross-sectional study recruiting adult patients with a diagnosis of bipolar disorder (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria) who had been hospitalized due to an acute manic episode with a Young Mania Rating Scale total score greater than 20. Bivariate correlational and multiple linear regression analyses were performed to identify independent predictors of LOS. RESULTS: A total of 235 patients from 44 centers were included in the study. The only factors that were significantly associated to LOS in the regression model were the number of previous episodes and the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at admission (P < 0.05). CONCLUSIONS: Patients with a high number of previous episodes and those with depressive symptoms during mania are more likely to stay longer in hospital. Patients with severe depressive symptoms may have a more severe or treatment-resistant course of the acute bipolar manic episode.

Prevalence of depression and its relationship with other clinical characteristics in a sample of patients with stable schizophrenia.

AIM: To evaluate the prevalence of depression using the Calgary Depression Scale for Schizophrenia (CDSS) in a sample of Spanish patients with stable schizophrenia and without a diagnosis of depression. METHODS: We included stable outpatients of 18 to 50 years of age, with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder who had not been diagnosed with depression. In this cross-sectional study, we administered the CDSS, the Positive and Negative Syndrome Scale (PANSS), the Scale for the Assessment of Negative Symptoms (SANS), the Scale to Assess Unawareness of Mental Disorder (SUMD), the Simpson Angus Scale (SAS), and the Barnes Akathisia Rating Scale (BARS). RESULTS: A total of 95 patients were recruited, 90 of them were included in the statistical analysis. Twenty-eight patients had a total score of 5 or more points on the CDSS, making the prevalence of depression 31% (95% confidence interval, 22-41). The CDSS had a high correlation with the depressive factor of the PANSS and a moderate correlation with the general psychopathology subscale of the PANSS. The correlation of the CDSS total score with negative symptoms was moderate using the SANS and low with the PANSS-negative. There was no correlation between depressive symptoms and positive symptoms, insight, and extrapyramidal symptoms; and the correlation with akathisia was low. CONCLUSION: Our results suggest that patients with stable schizophrenia who have not been diagnosed with depression frequently have clinically relevant symptoms of depression, and that these symptoms, with the possible exception of a contribution from negative symptoms, are not secondary to other symptoms of their disorder or to extrapyramidal adverse effects of medications.

A double-blind, placebo-controlled, randomized pilot study comparing quetiapine with placebo, associated to naltrexone, in the treatment of alcohol-dependent patients.

The objective of this study was to determine whether quetiapine plus naltrexone is more effective than naltrexone alone for the treatment of alcohol-dependent patients. This was a double-blind, randomized clinical trial where eligible alcohol-dependent patients were randomized to receive naltrexone (50mg/day) plus quetiapine (25-200mg/day) or naltrexone (50mg/day) plus placebo for 12 weeks, and afterwards patients received naltrexone alone during 4 additional weeks. The primary efficacy measures were percent days abstinent, drinks per drinking day, and the relapse rate. Sixty-two patients received a single-blind treatment with placebo plus naltrexone, and they were thereafter randomly assigned to quetiapine plus naltrexone (n=30) or placebo plus naltrexone (n=32). Eleven (36.7%) patients in the quetiapine-treated group and 4 (12.5%) patients in the placebo-treated group withdrew before they completed 12 weeks of treatment. There were no statistically significant differences for any primary drinking outcomes between treatment groups. Both regimens were well tolerated. This study failed to demonstrate any additional benefit from the combination of quetiapine and naltrexone compared to naltrexone alone on drinking outcomes.

Quetiapine in the treatment of sleep disturbances associated with addictive conditions: a retrospective study.

Sleep disturbances are a common finding in the clinical practice of addictions. Clinical management of insomnia is known to influence the prognosis of the addiction and the success of the detoxication process itself (Peles, Schreiber, and Adelson, 2006; Pace-Schott, Stickgold, Muzur, Wigren, Ward, et al., 2005; Bootzin and Stevens, 2005; Maher, 2004). Thus the relevance of controlling sleep disturbances from the very beginning of the detoxification process. However, managing this situation is often not easy for the clinician. The classical option of using sedating-hypnotic drugs to treat insomnia in polydrug users presents objections: the tolerance associated to high doses of benzodiacepines chronic abuse in many drug addicts obliges the clinician to use high doses of hypnotics, both in acute detoxification and the following de-habituation, with the associated resulting risk of dependence and undesirable side effects (excessive sedation, nocturnal enuresis, ataxia, etc).