Identifying potential adverse effects by patients' ratings: a proof-of-concept study of a novel approach.

OBJECTIVE: Methods to evaluate adverse effects of medications are significantly underdeveloped compared to those for efficacy. In this pilot proof-of-concept study, we preliminarily compared a novel approach-the Symptom Assessment Tool (SAT)-to a systematic and detailed assessment by a physician for identifying symptoms that were potentially adverse effects (sensitivity) and excluding symptoms that were unlikely to be adverse effects (specificity). METHODS: A symptom inventory and rating of symptom severity were completed before starting a psychotropic medication (or increasing its dose), and again 2 weeks later. Each symptom was systematically assessed by the patient-rated SAT and by a physician and was classified as either a potential or unlikely adverse effect. The primary analysis compared the classification of symptoms by the SAT to that by the physician. Potential adverse effects were also subcategorized as possible or probable adverse effects. RESULTS: A sample of 193 symptoms from 15 adults was evaluated, only 37.3% of which were considered potential adverse effects by the physician. Sensitivity of the SAT compared to physician's assessment was 90.3% for potential adverse effects and 97.5% for the subgroup of probable adverse effects. The SAT correctly identified 63.6% of the symptoms as unlikely adverse effects (specificity), and its negative predictive value was 91.7%. CONCLUSIONS: The SAT, appropriate for its intended use as a screening tool, had high sensitivity and moderate specificity and could present physicians with a limited number of potential adverse effects for further assessment and intervention. Further evaluation and refinement of this approach is warranted.

The impact of mood disorders and their treatment on the pregnant woman, the fetus, and the infant.

Treatment of mood disorders in pregnant or nursing women can carry significant risks for the mother and the developing infant. For patients and physicians, it may be difficult to obtain current information to make the proper decisions regarding pharmacologic and alternative treatments. Thus, this paper discusses the risks and benefits of pharmacologic treatment and the risks of not treating depression and bipolar disorder in the pregnant woman. The safety of treatment options is reviewed. Alternative treatment options are also discussed.

Gender differences in adolescent substance abuse.

Gender differences in the epidemiology, comorbidities, and treatment responses of substance abuse have been described in adults. However, a growing body of data suggests that gender differences also exist in adolescents with substance abuse. Unfortunately, research is still limited in this age group. This article reviews gender differences in the diagnosis, presentation, course of illness, and treatment response of substance abuse in adults and adolescents. Adolescent substance abuse treatments that take into account these gender differences are also discussed.

Biologic basis of bipolar disorder in children and adolescents.

Bipolar disorder is a serious and difficult-to-treat condition in any age group. In childhood and adolescence, diagnosis and treatment present specific challenges, as the disorder often manifests in atypical presentations, such as marked irritability and frequent alterations of mood states not typically seen in adults. The lack of double-blind, placebo-controlled studies in pediatric populations also leads to many difficult pharmacologic challenges. In this paper, we review available studies in neuroanatomy, neurochemistry, neurocognitive functioning, and genetics to further explore the underlying neurobiologic mechanisms of child and adolescent bipolar disorder. Future investigation should elicit distinct mechanisms for diagnosing and treating bipolar disorder from a neurobiologic perspective.

Suicide in preadolescents: who is at risk?

Suicidal behavior (ie, thoughts and attempts) in children is an issue of serious concern. In the past, suicide in young children has been largely denied and ignored. However, this is no longer possible, as accumulating evidence supports the existence of suicidal thoughts and actions in preadolescent children. This article explores suicidal behavior in preadolescent children and highlights areas of needed research.

Impact of depression and its treatment on the bones of growing children.

Depression in adults has been linked to reduced bone mineral density (BMD), osteoporosis, and increased incidence of fractures. Physiologic factors, such as hypothalamic-pituitary-adrenal axis dysfunction and increased circulation of inflammatory cytokines, may adversely impact bone metabolism. In addition, behavioral factors, such as reduced physical activity and altered dietary intake (especially of bone-related nutrients such as calcium and vitamin D), may be implicated. Antidepressant medications also may have an impact on BMD. Childhood and adolescence may be times of particular vulnerability to the adverse effects of depression due to the rapid bone mineral accrual that occurs during periods of growth. This article will review potential contributing factors and resulting consequences of depression on BMD in these populations and also explore areas of needed research.

Depression in children and adolescents: does gender make a difference?

The occurrence of depression is higher in females after puberty, suggesting a gender-related difference. This article reviews studies that have examined gender differences in the presentation and treatment of depression in adults and discusses how this information applies to depressed children and adolescents. The adult literature suggests that men and women vary in presentation of depression. In addition, differences exist in the pharmacokinetic properties of various medications, but it is unclear how they affect clinical treatment response. Studies of gender differences in child and adolescent depression are limited. Some studies suggest that differences seen in adults may also apply to children and adolescents. Studies of gender differences in treatment response are not available, however. Further study and evidence-based exploration are required to better understand gender differences in depression in children and adolescents.

Effects of cigarette smoking and nicotine nasal spray on psychiatric symptoms and cognition in schizophrenia.

Schizophrenic patients have among the highest rates of smoking of any group of patients. Previous studies have identified psychophysiological and potential nicotinic receptor abnormalities which may be associated with this phenomenon. The effects of acute smoking or acute administration of nicotine nasal spray, after smoking abstinence, on negative symptoms and neurocognitive function have been less extensively studied in experimental designs. This study investigated the effects of smoking of high nicotine or denicotinized cigarettes, and receiving active or placebo nicotine nasal sprays, on positive and negative symptoms and cognitive functions in schizophrenic patients. The study utilized a placebo controlled crossover experimental design with pre- and post-drug evaluations on each experimental day. Smoking high nicotine cigarettes decreased negative symptoms more than denicotinized cigarettes, but smoking neither cigarette changed scores of positive symptoms, anxiety, or depression. Active nicotine nasal spray did not differentially decrease negative symptoms compared with placebo, but did improve performance on a spatial organization task, and tended to improve some measures of verbal memory and two-choice reaction time in schizophrenic patients. Both high and denicotinized cigarettes improved performance on the spatial processing task, but there was no statistically significant differential drug (Cigarette type) effect. These results suggest that acute smoking of cigarettes may transiently decrease negative symptoms in patients with schizophrenia, but it is unclear whether this effect is attributable to nicotine, other components of cigarettes, or the act of smoking. Nicotine nasal spray may modestly improve some selected aspects of cognitive function in schizophrenia.