ABSTRACT
Depressive disorders are one of the most common mental disorders globally and progress in treating these disorders has been hampered, in part, by a lack of suitable nonclinical efficacy tests. Two common tests used in nonclinical efficacy studies of antidepressants-the forced swim test (FST) and tail suspension test (TST)-have come under criticism in recent years for their inconsistency and lack of validity, yet they continue to be used in the pharmaceutical industry. In this review, we provide a rationale for why international pharmaceutical regulatory and guidance agencies should begin issuing direction on methods for non-clinical efficacy testing that traditionally use the FST and TST, particularly considering that some regulators, such as those in the U.S. and E.U., allow the authorization of clinical trials to proceed without requiring tests in animals. The area of antidepressant drug discovery represents an important opportunity for reducing the attrition of psychiatric drugs, harmonizing regulatory requirements, and reducing animal use. Specific recommendations for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have been provided.
Subject(s)
Antidepressive Agents , Drug Development , Hindlimb Suspension , Swimming , Antidepressive Agents/pharmacology , Animals , Drug Development/methods , Humans , Drug Evaluation, Preclinical/methods , Behavior, Animal/drug effectsABSTRACT
Comment on "The fate of surplus laboratory animals" by Wewetzer et al.
ABSTRACT
Objective: The aim of this study was to assess whether self-report scales and neuropsychological tests used for adult patients with ADHD can help to distinguish between ADHD-specific and depressive symptoms. Method: In a cross-sectional design, differences in self-report questionnaires and neuropsychological tests among clinical subgroups and healthy controls (HC) were evaluated. Patients in clinical groups were diagnosed with major depressive disorder (MDD) or ADHD with or without depressive symptoms according to Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) guidelines. Results: The Hyperactivity subscales of the Conners' Adult ADHD Rating Scale (CAARS) differed between MDD and ADHD, whereas self-concept and inattention scales even distinguished comorbidity subgroups within the ADHD population. A reduced alertness and higher variations in reaction times measured by performance tests indicated problems in sustained attention in ADHD patients compared with HC. Conclusion: The diagnostic process of ADHD, and thereby the distinction from other symptom-overlapping, comorbid mental disorders, might be improved by utilizing ADHD-specific self-report questionnaires and neuropsychological tests, which are short, cost-effective, and standardized screening methods.
Subject(s)
Attention Deficit Disorder with Hyperactivity , Depressive Disorder, Major , Adult , Attention Deficit Disorder with Hyperactivity/diagnosis , Attention Deficit Disorder with Hyperactivity/epidemiology , Cognition , Cross-Sectional Studies , Depression , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/epidemiology , Humans , Psychiatric Status Rating ScalesABSTRACT
INTRODUCTION: The aim of this study was to assess cognitive differences between male and female adults with Attention Deficit Hyperactivity Disorder (ADHD). METHODS: Patients with an ADHD diagnosis according to the DSM-IV guidelines were included in a cross-sectional study evaluating cognitive measures. 28 women and 41 men from ages 19 to 56 completed self-report questionnaires and performed a computer-based test of attentional performance (TAP). The TAP assesses cognitive functions highly affected in ADHD patients, including working memory, alertness and attention as well as behavioral control and response inhibition. RESULTS: There were no measurable differences in self-report scales assessing current symptomology between the sexes, however men scored higher on the scale for childhood symptoms. Performance measures for general wakefulness were comparable between men and women, while working memory and behavioral control test results differed. Females reacted significantly slower and more unstable for both the TAP Go/NoGo paradigm and working memory subtest, while also making more errors in the latter. CONCLUSIONS: We found gender-specific effects regarding working memory and behavioral control in this sample of adult patients with ADHD. Further studies are warranted, examining whether these differences relate to differences in clinical presentation and comorbidity patterns between men and women.
