Innovations In Clinical Neuroscience

MAR-APR 2018

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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40 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE March-April 2018 • Volume 15 • Number 3–4 O R I G I N A L R E S E A R C H the symptomatic presentation and treatment history of patients with GAD who were seeking new treatment. The site-independent reviewers examined the impact of the presenting anxious symptoms on behavior and function to determine whether the symptoms caused sufficient distress to warrant a change in treatment. The "dual" review confirmed that these patients were suffering from excessive uncontrollable worry and had a cluster of anxiety symptoms that caused distressing and/or disruptive behavioral and/ or functional consequences in their lives despite receiving adequate anxiolytic treatment. In fact, 65 patients (72.2%) reported achieving less than a 25-percent response on their current regimen of antidepressant/anxiolytic medication(s). In this study population, every eligible patient endorsed excessive worry, and most endorsed all six of the associated anxiety symptoms listed in the DSM- IV-TR checklist for Criterion C. The mean total site- based HAM-A score of 27.1 and the mean CGI-S score of 4.8 reflect a moderately ill population of patients with anxiety. Hence, these patients with GAD warranted a different treatment intervention to address their disruptive symptom profile. The clinical characteristics and consequential distress reported in this GAD study population are consistent with the GAD treatment guidelines issued by the National Institute for Health Care Excellence (NICE) in 2011, which recommends drug treatment if the persistent anxious symptoms cause marked functional impairment as reflected by difficulty in functioning in the domains of work or school, social or leisure, and/or family life. 22 Limitations. This analysis has limitations that require cautious interpretation of the findings. We only enrolled patients with GAD who needed a change in their current antidepressant medication, and thus we did not assess patients with GAD who were either untreated or successfully treated. We limited our study to patients with GAD and did not explore the characterization of patients with other anxiety disorders or patients with GAD and comorbid acute depression. This was a drug trial to assess a different medication, and we did not consider alternative treatment regimens, such as complementary or alternative medicines. Further, we did not examine the treatment outcome or the placebo at the end of this trial. The diagnosis of GAD is often comingled with depressive disorders, other anxiety disorders (e.g., social anxiety or panic disorders), or substance abuse disorder or dependency problems. 6,9,23,24 In fact, anxiety symptoms can be masked by TABLE 1. Demographic and clinical characteristics of patients with GAD (N=90) SEX, N 90 Male, n 23 Female, n 67 AGE, mean±SD (range) 41.2±13.7 (20–64) BODY MASS INDEX, mean±SD (range) 31.5±7.1 (18.3–49.6) GAD DIAGNOSIS, % (range) Made ≤1 year ago 15.5 Made >5 years ago 58.8 Made >10 years ago 37.7 (10–40) DURATION OF CURRENT EPISODE In months, mean±SD (range) 130.3±145.8 (6–480) <12 months, % 5.7 SYMPTOM SEVERITY MEASURES, mean ± SD (range) SIGH-A 27.1±3.7 (20–40) CGI-S 4.8±0.6 (4–6) CAS 11.1±1.4 (9–15) RDS 5.2±1.1 (3–7) GAD-7 (patient-rated) 16.4±3.9 (6–21) MINI ENDORSED COMORBIDITIES, % Current MDE 4.4 Past history of a MDE 33.3 Past history of recurrent MDD 18.9 Past history of bipolar disorder 0.0 Current social phobia (social anxiety) 5.6 Past history of panic disorder 6.7 Past history of a psychotic episode 1.1 Past history of PTSD or obsessive-compulsive disorder 1.1 Past history of anorexia or bulimia nervosa 0.0 Any current suicidal ideation 12.2 CRITERION B. DIFFICULTY CONTROLLING WORRY, % 100.0 CRITERION C. ASSOCIATED SYMPTOMS, % Restlessness 98.9 Tired, easily fatigued 92.1 Difficulty concentrating 94.3 Irritability 89.8 Muscle tension 87.5 Sleep disturbance 94.3 CRITERION E. CLINICALLY SIGNIFICANT DISTRESS, % Anxieties disrupt work, school, or functioning 100.0 GAD: generalized anxiety disorder; SD: standard deviation; SIGH-A: Structured Interview Guide for the Hamilton Anxiety Rating Scale; CGI-S: Clinical Global Impression of Severity; CAS: Covi Anxiety Scale; ns: not significant; RDS: Raskin Depression Scale; MDE: major depressive episode; MDD: major depressive disorder; PTSD: posttraumatic stress disorder

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