quetiapine-fumarate and Xerostomia

Evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) once-daily monotherapy for patients with major depressive disorder (MDD).. In this 10-week, (8-week active treatment phase and 2-week drug-discontinuation/tapering phase), multicenter, parallel-group, placebo-controlled, double-blind, randomized, Phase III study (D1448C00003: Opal), patients initially received quetiapine XR 150 mg/day or placebo. At Week 2, inadequate responders (<20% reduction in MADRS total score) were up-titrated to 300 mg/day quetiapine XR or matching placebo for the final 6 weeks. Primary endpoint: change from randomization to Week 8 in MADRS total score. Secondary endpoints included: MADRS response (≥50% reduction in total score from randomization) and changes from randomization to Week 8 in HAM-D and CGI-S.. 310 patients were randomized. At Week 8, quetiapine XR significantly reduced mean MADRS total score versus placebo (-16.49 vs -13.10, respectively; p<0.01). Mean MADRS score was significantly reduced by quetiapine XR versus placebo at Week 1 (p<0.05). MADRS response rates were significantly greater at Week 8 for quetiapine XR versus placebo (61.9% vs 48.0%, respectively; p<0.05). Significant changes in HAM-D total score and CGI-S were seen at Week 8 for quetiapine XR versus placebo. Withdrawal rates due to AEs were 9.9% and 2.6% for quetiapine XR and placebo, respectively. Common AEs (>10% any group during the randomized phase) for quetiapine XR and placebo, respectively were dry mouth (32.9% and 6.5%), sedation (21.7% and 1.9%), somnolence (20.4% and 5.2%), and headache (10.5% and 10.3%).. The study was not designed to compare quetiapine XR 150 mg/day and 300 mg/day; it was intended to reflect dose titration that might occur in clinical practice.. Quetiapine XR monotherapy is effective in patients with MDD, with symptom improvement seen as early as Week 1, and tolerability results consistent with the known profile of quetiapine.

Topics: Administration, Oral; Adolescent; Adult; Aged; Antipsychotic Agents; Delayed-Action Preparations; Depressive Disorder, Major; Dibenzothiazepines; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Headache; Humans; Male; Middle Aged; Psychiatric Status Rating Scales; Quetiapine Fumarate; Time Factors; Treatment Outcome; Xerostomia; Young Adult

Data on the efficacy of quetiapine in borderline personality disorder (BPD) are still scarce. We aimed to investigate the efficacy of quetiapine for impulsivity and a broad range of affective symptoms in BPD. In this 12-week open-label study, we included individuals with BPD who presented to psychiatric in- and outpatient services. After a gradual titration of quetiapine, a flexible dose (range, 100-800 mg) was administered. The main outcome measures consisted of the scores on patient-rated questionnaires (Barratt Impulsiveness Scale, Buss-Durkee Hostility Inventory, Affective Lability Scale, Spielberger State and Trait Anxiety Inventory, Spielberger State and Trait Anger Inventory, and Beck Depression Inventory) and on neurocognitive tasks related to impulsivity (Stroop Color Word Task and IOWA Gambling Task). A mixed linear model, correcting for age, sex, antidepressant use, and weeks in psychotherapy, was applied. Forty-one patients (34 females and 7 males; mean [SD] age, 27.0 [9.0] years) were enrolled in the study, 32 of which completed the trial. Patients' scores decreased significantly (mean [SD] difference; P value) on the Barratt Impulsiveness Scale (19.7 [2.0]; P < 0.0001), Buss-Durkee Hostility Inventory (11.5 [1.4]; P < 0.0001), Affective Lability Scale (0.75 [0.08]; P < 0.0001), Beck Depression Inventory (25.0 [1.7]; P < 0.0001), Spielberger State and Trait Anxiety Inventory state (19.9 [1.9]; P < 0.0001) and trait (20.8 [1.7]; P < 0.0001) subscale, and Spielberger State and Trait Anger Inventory state (7.3 [1.1]; P < 0.0001) and trait (10.1 [1.0]; P < 0.0001) subscale. In addition, patients showed significantly less inference on the Stroop Color Word Task and had more 'good choices' on the IOWA Gambling Task. These results suggest that quetiapine may be efficacious in the treatment of impulsivity and affective symptoms in BPD.

Topics: Adult; Affective Symptoms; Aggression; Anger; Antipsychotic Agents; Borderline Personality Disorder; Depression; Dibenzothiazepines; Disorders of Excessive Somnolence; Female; Humans; Impulsive Behavior; Male; Neuropsychological Tests; Patient Dropouts; Patient Satisfaction; Quetiapine Fumarate; Receptors, Dopamine D2; Sex Factors; Test Anxiety Scale; Treatment Outcome; Xerostomia

The monaminergic properties of second generation antipsychotics are prompting research on their use to treat cocaine dependence, with inconclusive results to date. In preliminary reports, the atypical antipsychotic quetiapine has shown promise for the treatment of substance abuse disorders. The primary objective of the current study was to assess the efficacy of quetiapine in reducing cocaine cravings and use in nonpsychotic subjects with cocaine dependence over 6 weeks of open-label treatment. Twenty-two cocaine-dependent, nonpsychotic men were initiated to open-label treatment with quetiapine (300-600 mg/d). The primary outcome measure was weekly self-report of cocaine cravings as assessed with the Brief Substance Craving Scale. Cocaine use was captured with a self-report Timeline Follow-back calendar, administered every 2 weeks. Side effect monitoring was conducted weekly, and movement disorders were assessed every 2 weeks. Intent-to-treat regression analyses (n = 22) indicated that the Brief Substance Craving Scale total score decreased significantly overtime (P < 0.001). Self-reports also suggested decreased cocaine use. There was no treatment-related increase in movement disorders, and most side effects were mild. However, all subjects did experience sedation, and several subjects dropped out because of it. What is more, weight increased significantly over time (P < 0.001). Open-label quetiapine treatment reduced cravings and improved some aspects of cocaine dependence in nonpsychotic individuals. Additional research is needed to confirm the current findings and to further delineate the role quetiapine may play in the treatment of cocaine use disorders.

Topics: Adult; Antipsychotic Agents; Cocaine-Related Disorders; Diagnostic and Statistical Manual of Mental Disorders; Dibenzothiazepines; Drug Administration Schedule; Humans; Male; Middle Aged; Patient Compliance; Quetiapine Fumarate; Severity of Illness Index; Syncope; Tablets; Time Factors; Treatment Outcome; Weight Gain; Xerostomia

Second-generation antipsychotics with a favorable tolerability profile have offered new treatment options for patients with borderline personality disorder. Sparse data are available on the use of quetia-pine in treating this disorder. The aim of the present study is to investigate efficacy and tolerability of quetia-pine in a group of patients with borderline personality disorder.. Fourteen consecutive outpatients with a DSM-IV diagnosis of borderline personality disorder were treated for 12 weeks with open-label quetiapine at the dose of 200-400 mg/day. Patients were assessed at baseline, week 4, and week 12 with the Clinical Global Impressions (CGI) severity item, the Brief Psychiatric Rating Scale (BPRS), the Hamilton Rating Scale for Depression (HAM-D), the Hamilton Rating Scale for Anxiety (HAM-A), the Social and Occupational Functioning Assessment Scale (SOFAS), the Borderline Personality Disorder Severity Index (BPDSI), and the Barratt Impulsiveness Scale-version 11 (BIS-11). Adverse effects were evaluated using the Dosage Record and Treatment Emergent Symptom Scale. Statistical analysis was performed with the ANOVA for repeated measures. Significant p values were < or = .05.. Eleven patients completed the study. Three patients (21.4%) dropped out due to excessive somnolence or noncompliance. The mean +/- SD dose of quetia-pine was 309.09 +/- 83.12 mg/day. A significant change was found for the scores of the following scales: CGI severity item, BPRS, HAM-A, SOFAS, BPDSI total score, BPDSI items "impulsivity" and "outbursts of anger," and BIS-11. Common adverse effects were mild-to-moderate somnolence, dry mouth, and dizziness.. Initial data suggest that quetiapine is efficacious and well tolerated in treating patients who have borderline personality disorder, particularly when impulsiveness/aggressiveness-related symptoms are prominent. At the moment, no reliable comparison is available in the literature. Double-blind controlled trials are needed to verify these findings.

Topics: Adult; Aggression; Analysis of Variance; Anger; Antipsychotic Agents; Borderline Personality Disorder; Dibenzothiazepines; Disorders of Excessive Somnolence; Dizziness; Drug Administration Schedule; Female; Humans; Impulsive Behavior; Male; Pilot Projects; Psychiatric Status Rating Scales; Quetiapine Fumarate; Severity of Illness Index; Treatment Outcome; Xerostomia

Although serotonin reuptake inhibitors (SRIs) are the most effective pharmacologic treatment currently available for patients with obsessive-compulsive disorder (OCD), 40% to 60% of patients do not respond to this treatment. This study was conducted to evaluate the efficacy and tolerability of quetiapine in addition to an SRI for treatment-refractory patients with OCD.. Forty patients (10 men/30 women, mean +/- SD age = 35.2 +/- 12.1 years; range, 18-60 years) with primary OCD according to DSM-IV criteria who were recruited between February 2001 and December 2002 were randomly assigned in an 8-week, double-blind, placebo-controlled trial to receive dosages titrated upward to 300 mg/day of quetiapine (N = 20) or placebo (N = 20) in addition to their SRI treatment. At entry, all patients were unresponsive to courses of treatment with at least 2 different SRIs at a maximum tolerated dose for 8 weeks. During the study, primary efficacy was assessed according to change from baseline on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). A responder was defined as having a final Clinical Global Impressions-Improvement scale rating of "very much improved" or "much improved" and a decrease of > or = 35% in Y-BOCS score.. An intent-to-treat, last-observation-carried-forward analysis demonstrated a mean +/- SD decrease in Y-BOCS score of 9.0 +/- 7.0 (31%) in the quetiapine group and 1.8 +/- 3.4 (7%) in the placebo group (F=16.99, df=1,38; p <.001). Eight (40%) of 20 patients in the quetiapine group and 2 (10%) of 20 patients in the placebo group were responders (chi2=4.8, df=1, p=.028). The most common side effects in the quetiapine group were somnolence, dry mouth, weight gain, and dizziness.. The results of this study show that quetiapine in addition to an SRI is beneficial for patients with OCD who do not respond to SRI treatment alone.

Topics: Adolescent; Adult; Ambulatory Care; Antipsychotic Agents; Diagnostic and Statistical Manual of Mental Disorders; Dibenzothiazepines; Dizziness; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Obsessive-Compulsive Disorder; Placebos; Psychiatric Status Rating Scales; Quetiapine Fumarate; Selective Serotonin Reuptake Inhibitors; Sleep; Treatment Outcome; Xerostomia

Lamotrigine and quetiapine are commonly used in bipolar disorder, but there are no published systematic studies of their use in combination for treatment-resistant bipolar depression.. We studied 39 trials in outpatients (15 with bipolar I disorder, 22 with bipolar II disorder, and 1 with bipolar disorder not otherwise specified; 1 patient had 2 trials) with depression resistant to quetiapine or lamotrigine who were taking a mean of 1.7 other prescription psychotropic medications. Patients were given either open-label lamotrigine or quetiapine naturalistically, for up to 12 weeks of combination therapy.. Lamotrigine (mean dose, 204.2 mg/d) plus quetiapine (mean dose, 188.5 mg/d) increased the euthymia rate (0.0% to 46.2%), decreased syndromal (79.5% to 30.8%) and subsyndromal (20.5% to 15.4%) depression rates, and improved Clinical Global Impression-Severity (mean change, -1.0) and Global Assessment of Functioning (mean change, +5.9) scores. Approximately one-fifth of patients discontinued therapy (20.5%) or required subsequent additional pharmacotherapy (20.5%). Only 10.3% discontinued due to adverse effects, and there was no significant change in mean body weight.. The findings of this uncontrolled open pilot study must be viewed with caution. However, randomized, double-blind, placebo-controlled studies are warranted to confirm the possibility that combination therapy with lamotrigine and quetiapine is effective and well tolerated in patients with treatment-resistant bipolar depression.

Topics: Adult; Affect; Antimanic Agents; Antipsychotic Agents; Bipolar Disorder; Diagnostic and Statistical Manual of Mental Disorders; Dibenzothiazepines; Drug Resistance; Drug Therapy, Combination; Female; Humans; Interview, Psychological; Lamotrigine; Male; Middle Aged; Monitoring, Physiologic; Pilot Projects; Psychiatric Status Rating Scales; Quetiapine Fumarate; Severity of Illness Index; Treatment Outcome; Triazines; Xerostomia