Ramelteon for insomnia symptoms in a community sample of adults with generalized anxiety disorder: an open label study.

OBJECTIVE: Prior research confirms the relationship between insomnia and psychiatric disorders, particularly anxiety and depression. The effectiveness and tolerability of ramelteon was examined in adult generalized anxiety disorder (GAD) patients with insomnia symptoms. METHODS: Twenty-seven adults with sleep disturbance meeting DSM-IV diagnostic criteria for GAD and partially responsive on an SSRI or SNRI by randomization visit (as signified by a Hamilton Anxiety scale [HAMA] maximum score of 15 and minimum of 8, Clinical Global Impressions Severity of Illness [CGI-S] scale of < or = 4 and > or = 2 [measuring anxiety symptoms], CGI-S of 4 [measuring insomnia symptoms], > or = 5 on the Pittsburgh Sleep Quality Index [PSQI], and > or = 10 on the Epworth Sleepiness Scale [ESS]) were treated openly for 10 weeks on ramelteon 8 mg at bedtime. Analysis was conducted using repeated measures methodology. Patient reported sleep diaries were maintained throughout the study. RESULTS: Significant symptom reduction was observed on all scales (HAMA, ESS, CGI-I, CGI-S), with subjects falling asleep faster and sleeping longer. Headache upon stopping ramelteon, daytime tiredness, agitation, and depression were the most commonly reported side effects and were cited as transient. CONCLUSION: Data from this 12-week open-label study suggests ramelteon is an effective and generally well tolerated treatment for insomnia symptoms in this community sample of adults with GAD.

Safety and efficacy of bupropion extended release in treating a community sample of Hispanic and african american adults with major depressive disorder: an open-label study.

OBJECTIVES: Many publications and federal agencies call for more trials and research on the effectiveness of medications and treatment needs in diverse patient populations with psychiatric disorders. This study investigates the effectiveness of bupropion extended release (XL) on a community sample of men and women of either Hispanic or African American heritage with major depressive disorder (MDD). METHOD: Twenty-six patients of Hispanic or African American descent with MDD as diagnosed by means of the Structured Clinical Interview for DSM-IV Axis I Disorders were required to have a score of 20 or greater on the Hamilton Rating Scale for Depression (17-item) (HAM-D-17) at baseline and prior to randomization. Patients were also required to have a score of 4 or greater on the Clinical Global Impressions-Severity of Illness scale (CGI-S) at baseline and prior to initiation of treatment. Patients were treated openly for an optimum of 9 weeks. Bupropion XL was initiated at 150 mg daily and then increased to 300 mg daily after 1 week and 450 mg daily 4 weeks later if judged clinically necessary by the investigator. Tools utilized for repeated-measures methodology indicating efficacy were the HAM-D-17, CGI-S, Clinical Global Impressions-Improvement scale (CGI-I), Change in Sexual Functioning Questionnaire (CSFQ), and the 18-item Motivation and Energy Inventory. The study was conducted from February 9, 2005, to March 23, 2006. RESULTS: Efficacy was demonstrated on the HAM-D-17, CGI-S, CGI-I, and CSFQ (p < .05). Mean times ranged from 50% symptom reduction in about 2 weeks to 90% symptom reduction in less than 2 months. Dry mouth, transient stomach discomfort, and headache were the most commonly reported side effects. CONCLUSIONS: Data from this 10-week open-label study suggest bupropion XL is an effective and well tolerated treatment for depressive symptoms in the moderately to markedly ill Hispanic and African American community.

Effects of Paroxetine CR on Depressive and Anxiety Symptoms: In a Community Sample of Adult Hispanic Women with Major Depression or Generalized Anxiety Disorder.

OBJECTIVE: Previous research reports higher rates of depression in Hispanic women than Caucasian or African American women. The effectiveness and tolerability of paroxetine CR (controlled release) was examined in women of Hispanic heritage with depression or anxiety. METHODS: Thirty-six Hispanic female patients 18 years or older meeting DSM-IV criteria for major depression or generalized anxiety disorder diagnosis with an initial Hamilton Depression Rating scale (17 item) Z20 or Hamilton Anxiety Rating scale Z18 measuring no less than 4 on the Clinical Global Impression Severity scale received paroxetine CR (12.5-50mg/day) for 29 weeks of open label treatment. Analysis was conducted using repeated measures methodology. RESULTS: Significant symptom reduction was observed on all scales. Mean dose was 31.7mg. The side effect of sexual dysfunction (17%) appeared most frequently but did not cause any patients to cease study participation. CONCLUSIONS: Paroxetine CR was an effective and generally well tolerated treatment in this population.