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The objective of these studies was to evaluate the efficacy and tolerability of tiagabine, a selective gamma-aminobutyric acid reuptake inhibitor, in adult patients with generalized anxiety disorder (GAD). Patients with a diagnosis of GAD were enrolled in 1 of 3 randomized, placebo-controlled, 10-week studies. In each study, tiagabine was taken twice daily in divided doses--4, 8, or 12 mg/d in a fixed-dose study and 4-16 mg/d in two flexible-dose trials. The primary efficacy measure was the change from baseline in the 14-item Hamilton Rating Scale for Anxiety (HAM-A) total score at the final visit (last observation carried forward). Additional measures included change from baseline in the anxiety subscale of the Hospital Anxiety and Depression Scale, the Sheehan Disability Scale, and Clinical Global Impressions-Improvement scale. Tolerability was assessed via spontaneous reports as well as rating scales throughout the study period. In all 3 studies, there was no significant differentiation from placebo on the primary measure (change in HAM-A) for any tiagabine dose (P > 0.05). In the 2 flexible-dose studies, the tiagabine group showed improvements over time in the HAM-A that reached significance only in those patients who completed 10 weeks of treatment (study 2, P = 0.018; study 3, P = 0.036). The most common adverse events were dizziness, headache, nausea, fatigue, and somnolence. In conclusion, the results of these studies do not support the efficacy of tiagabine in adult patients with GAD.
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PMID:Tiagabine in adult patients with generalized anxiety disorder: results from 3 randomized, double-blind, placebo-controlled, parallel-group studies. 1848 Jun 88

It has been reported that more than half of the children in Japan suffer from daytime sleepiness. In contrast, about one quarter of junior high-school students in Japan complain of insomnia. According to the International Classification of Sleep Disorders (Second edition), these children could be diagnosed as having behaviorally-induced insufficient sleep syndrome due to inadequate sleeping habits. Getting on adequate amount of sleep should solve such problems;however, such a therapeutic approach often fails. Although social factors are involved in these sleep disturbances, I feel that a novel notion - asynchronization - leads to an understanding of the pathophysiology of disturbances in these children. Further, it could contribute to resolve their problems. The essence of asynchronization is a disturbance of various aspects (e.g., cycle, amplitude, phase, and interrelationship) of the biological rhythms that normally exhibits circadian oscillation. The main cause of asynchronization is hypothesized to be the combination of light exposure during night and the lack of light exposure in the morning. Asynchronization results in the disturbance of variable systems. Thus, symptoms of asynchronization include disturbances of the autonomic nervous system (sleepiness, insomnia, disturbance of hormonal excretion, gastrointestinal problems, etc.) and higher brain function (disorientation, loss of sociality, loss of will or motivation, impaired alertness and performance, etc.). Neurological (attention deficit, aggression, impulsiveness, hyperactivity, etc.), psychiatric (depressive disorders, personality disorders, anxiety disorders, etc.) and somatic (tiredness, fatigue, etc.) disturbances could also be symptoms of asynchronization. At the initial phase of asynchronization, disturbances are functional and can be resolved relatively easily, such as by the establishment of a regular sleep-wakefulness cycle;however, without adequate intervention the disturbances could gradually worsen and become hard to resolve.
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PMID:[A novel proposal explaining sleep disturbance of children in Japan--asynchronization]. 1863 11

To evaluate acute onset of anxiolytic activity using a dental anxiety model, 89 patients were randomised to double-blind single dose pregabalin 150 mg, alprazolam 0.5 mg or placebo 4 h before a scheduled dental procedure. A Dental Anxiety Total score >12 (moderate-to-severe) without meeting Diagnostic and Statistical Manual of Mental Disorders (Fourth edition) (DSM-IV) anxiety disorder criteria was required. Efficacy and safety, assessed 2, 2.5, 3, 3.5 and 4 h postdose, included 100 mm Visual Analogue Scale for Anxiety (VAS-Anxiety; primary outcome), 100 mm VAS-Sedation and Time-to-Onset of Action Scale (TOAS), a patient-rated anti-anxiety drug-benefit scale (no [0] to full benefit [10]). Mixed model analysis found significantly greater VAS-A improvement slopes for pregabalin (t = -2.47; P = 0.014) and alprazolam (t = -2.39; P = 0.018). There was a significant improvement versus placebo in the TOAS from 2 h through endpoint in alprazolam patients and from 3 h onward in pregabalin patients. Pregabalin produced significantly greater increases in VAS-Sedation versus placebo from 2.5 h through 4 h (2 h onward for alprazolam). Notably, there was a higher correlation between TOAS and VAS-Sedation (r = +0.58) than VAS-Anxiety (r = -0.50) on Spearman's analysis. The majority of Adverse Effects (AEs) were mild, and the most frequent for pregabalin, alprazolam, and placebo, respectively, were fatigue (N = 7, 7, 3), dizziness (N = 6, 3, 3), attention disturbance (N = 3, 1, 0), somnolence (N = 3, 0, 0), feeling abnormal (N = 0, 2, 0) and balance disorder (N = 0, 2, 0). These results suggest that onset of clinically meaningful anxiolytic effect after single-dose pregabalin occurs within the first 3-4 h. Additional research is needed to determine whether anxiolytic effect occurs in generalized anxiety disorder populations by day 1 or within 3-4 h post-first dose.
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PMID:Early onset anxiolytic efficacy after a single dose of pregabalin: double-blind, placebo- and active-comparator controlled evaluation using a dental anxiety model. 1863 90

Anxiety disorders are common in multiple sclerosis (MS). Chronic worry is the defining feature of generalized anxiety. Despite this, only one study has examined the impact of chronic worry in MS. The present investigation explored the relationship between excessive worry and common physical, emotional, and neuropsychological symptoms in a community-based sample of 50 patients with relapsing-remitting and secondary progressive MS. As expected, MS patients reported significantly more worry than a group of 45 healthy controls. Correlational analyses revealed that MS patients' elevated worry was associated with fatigue, sleep disturbance, problem-solving deficits, pain, and disability status. Follow-up analyses indicated that worry and anxiety may represent related but distinct constructs. Clinicians are urged to regularly monitor and treat pathological worry in MS.
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PMID:Clinical correlates of generalized worry in multiple sclerosis. 1910 77

Computerized ambulatory monitoring overcomes a number of methodological and conceptual challenges to studying mental disorders, however concerns persist regarding the feasibility of this approach with severe psychiatric samples and the potential of intensive monitoring to influence data quality. This multi-site investigation evaluates these issues in four independent samples. Patients with schizophrenia (n = 56), substance dependence (n = 85), anxiety disorders (n = 45), and a non-clinical sample (n = 280) were contacted to participate in investigations using computerized ambulatory monitoring. Micro-computers were used to administer electronic interviews several times per day for a one-week period. Ninety-five percent of contacted individuals agreed to participate in the study, and minimum compliance was achieved by 96% of these participants. Seventy-eight percent of all programmed assessments were completed overall, and only 1% of micro-computers were not returned to investigators. There was no evidence that missing data or response time increased over the duration of the study, suggesting that fatigue effects were negligible. The majority of variables investigated did not change in frequency as a function of study duration, however some evidence was found that socially sensitive behaviors changed in a manner consistent with reactivity.
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PMID:Computerized ambulatory monitoring in psychiatry: a multi-site collaborative study of acceptability, compliance, and reactivity. 1919 50

Although sleep complaints are common in depression and anxiety, there is little agreement as to how they should be organized and assessed. It is also unclear whether sleep complaints show specificity with certain disorders or whether they are nonspecific symptoms. The authors examined the structure of sleep complaints and the relations of these complaints to depression and anxiety in 3 samples: college students, older adults, and psychiatric patients. Exploratory and confirmatory factor analyses indicated that sleep complaints consistently defined 2 distinct dimensions: Insomnia and Lassitude. The Insomnia factor included indicators of early, middle, and late insomnia, as well as poor sleep quality. The Lassitude factor included measures of hypersomnia, fatigue, and sleepiness. Both factors were significantly related to symptoms and diagnoses of depression and anxiety. However, Lassitude was more strongly related to symptoms of depression and anxiety than was Insomnia. In addition, Lassitude showed specificity to measures and diagnoses of depression compared with anxiety disorders. This specificity can be explained by Lassitude's relation with negative and positive emotionality, both of which are components of depression.
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PMID:The two-factor structure of sleep complaints and its relation to depression and anxiety. 1922 24

Childhood sleep problems have been associated with a range of adverse cognitive and academic outcomes, as well as increased impulsivity and emotional disorders such as anxiety and depression. The aim of the study was to examine subjective reports of sleep-related problems in children with anxiety disorders during school and weekend nights. Thirty-seven children with clinically-diagnosed anxiety disorders and 26 non-clinical children aged 7-12 years completed an on-line sleep diary to track sleep patterns across school nights and weekend nights. Anxious children reported going to bed significantly later (p=0.03) and had significantly less sleep (p=0.006) on school nights compared to non-anxious children. No significant differences in sleep onset latency, number of awakenings or time awake during the night, daytime sleepiness, or fatigue were found between the two groups. On the weekends, anxious children fell asleep quicker and were less awake during the night than on weeknights. School-aged anxiety disordered children showed a sleep pattern that differs from their non-anxious peers. Although the mean 30 min less sleep experienced by anxious children may initially seem small, the potential consequences on daytime performance from an accumulation of such a sleep deficit may be significant, and further investigation is warranted.
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PMID:The sleep patterns and problems of clinically anxious children. 1923 45

The care of a patient in the intensive care unit extends well beyond his or her hospitalization. Evaluation of a patient after leaving the intensive care unit involves a review of the hospital stay, including principal diagnosis, exposure to medications, period spent in the intensive care unit, and history of prolonged mechanical ventilation. Fatigue should prompt evaluation for possible anemia, nutritional deficits, sleep disturbance, muscular deconditioning, and neurologic impairment. Other common problems include poor appetite with possible weight loss, falls, and sexual dysfunction. Psychological morbidities, posttraumatic stress disorder, anxiety disorder, and depression also often occur in the post-intensive care unit patient. These conditions are more common among patients with a history of delirium, prolonged sedation, mechanical ventilation, and acute respiratory distress syndrome. The physician should gain an understanding of the patient's altered quality of life, including employment status, and the state of his or her relationships with loved ones or the primary caregiver. As in many aspects of medicine, a multidisciplinary treatment approach is most beneficial to the post-intensive care unit patient.
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PMID:Treatment of the post-ICU patient in an outpatient setting. 1932 58

A multicenter, double-blind, parallel-group study was designed to assess the efficacy and safety of zolpidem extended-release coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Patients (N = 383) received open-label escitalopram 10 mg/d and were randomized to either adjunct zolpidem extended-release 12.5 mg or placebo. The primary efficacy measure was change from baseline to week 8 in subjective total sleep time. Secondary efficacy measures included subjective sleep onset latency, number of awakenings, wake time after sleep onset, sleep quality, the Hamilton Rating Scale for Anxiety, the Beck Anxiety Inventory, the Sleep Impact Scale, the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire, and the Sheehan Disability Scale. The last-observation-carried-forward method was used to impute missing values for most efficacy measures. Safety was monitored at each visit. At week 8 and all time points, there was a significant improvement in the zolpidem extended-release/escitalopram group compared with placebo/escitalopram for total sleep time (P < 0.0001). Most of the secondary efficacy measures also significantly favored zolpidem at most visits (P < 0.0001). The most common treatment-emergent adverse events in both groups were nausea, dizziness, headache, fatigue, and dry mouth. Concurrent zolpidem extended-release/escitalopram, compared with placebo/escitalopram, significantly improved insomnia and sleep-related next-day symptoms, but not anxiety symptoms, in patients with comorbid insomnia and generalized anxiety disorder.
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PMID:Zolpidem extended-release improves sleep and next-day symptoms in comorbid insomnia and generalized anxiety disorder. 1944 75

There is an increasing interest in the health risks related to the use of herbal remedies. Although most consumers think that phytomedicines are safe and without side effects, interactions between complementary alternative and conventional medicines are being described. The aim of this clinical case report is to highlight the importance of the safe use of herbal remedies by providing a clinical interaction study between pharmaceutical medicines and herbal medicinal products. The case of a patient self-medicated with Valeriana officinalis L. and Passiflora incarnata L. while he was on lorazepam treatment is described. Handshaking, dizziness, throbbing and muscular fatigue were reported within the 32 h before clinical diagnosis. The analysis of family medical history ruled out essential tremor, Parkinson's disease, Wilson's disease and other symptom-related pathologies. His medical history revealed a generalized anxiety disorder and medicinal plant consumption but no neurological disorder. Appropriate physical examination was carried out. An additive or synergistic effect is suspected to have produced these symptoms. The active principles of Valerian and passionflower might increase the inhibitory activity of benzodiazepines binding to the GABA receptors, causing severe secondary effects. Due to the increase in herbal product self-medication, the use of herbal remedies should be registered while taking the personal clinical history. Multidisciplinary teams should be created to raise studies on medicinal plants with impact on medical praxis.
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PMID:Interactions of Valeriana officinalis L. and Passiflora incarnata L. in a patient treated with lorazepam. 1944 Oct 67


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