Anxiety Disorders: Spann M

Allgulander C, Nutt D, Detke M, Erickson J, Spann M, Walker D, Ball SG, Russell JM. · Department of Clinical Neuroscience, Section of Psychiatry, Karolinska Institutet, Stockholm, Sweden. · J Psychopharmacol. · Pubmed #18635722 No free full text.

Abstract: The present study is a non-inferiority comparison of duloxetine 60-120 mg/day and venlafaxine extended-release (XR) 75-225 mg/day for the treatment of adults with generalized anxiety disorder (GAD). The non-inferiority test was a prespecified plan to pool data from two nearly identical 10-week, multicentre, randomized, placebo-controlled, double-blind studies of duloxetine 60-120 mg/day and venlafaxine 75-225 mg/ day for the treatment of GAD. An independent expert consensus panel provided six statistical and clinical criteria for determining non-inferiority between treatments. Response was defined as > or =50% reduction in Hamilton Anxiety Rating Scale (HAMA) total score. In the pooled sample, patients were randomly assigned to duloxetine (n = 320), venlafaxine XR (n = 333) or placebo (n = 331). For the non-inferiority analysis, the per-protocol patients who were treated with duloxetine (n = 239) or venlafaxine XR (n = 262) improved significantly more (mean HAMA reductions were -15.4 and -15.2, respectively) than placebo-treated patients (n = 267; -11.6, P < or = 0.001, both comparisons). Response rates were 56%, 58% and 40%, respectively. Discontinuation rate because of AEs was significantly higher for duloxetine (13.4%, P < or = 0.001) and venlafaxine XR (11.4%, P < or = 0.01) groups compared with placebo (5.4%). Duloxetine 60-120 mg/day met all statistical and clinical criteria for non-inferiority and exhibited a similar tolerability profile compared with venlafaxine XR 75-225 mg/day for the treatment of adults with GAD.

Llorca PM, Bodkin JA, Spann M, Ball SG, Russell JM, Ball SG. · No affiliation provided · J Clin Psychopharmacol. · Pubmed #19142122 No free full text.

This publication has no abstract.

Nicolini H, Bakish D, Duenas H, Spann M, Erickson J, Hallberg C, Ball S, Sagman D, Russell JM. · Grupo Medico Carracci, Mexico City, Mexico. · Psychol Med. · Pubmed #18485261 No free full text.

Abstract: BACKGROUND: This study examined the efficacy and tolerability of duloxetine and venlafaxine extended-release (XR) treatment for generalized anxiety disorder (GAD), with a secondary focus on psychic and somatic symptoms within GAD. METHOD: The design was a 10-week, multi-center, double-blind placebo-controlled study of duloxetine (20 mg or 60-120 mg once daily) and venlafaxine XR (75-225 mg once daily) treatment. Efficacy was measured using the Hamilton Anxiety Rating Scale (HAMA), which includes psychic and somatic factor scores. Tolerability was measured by occurrence of treatment-emergent adverse events (TEAEs) and discontinuation rates. RESULTS: Adult out-patients (mean age 42.8 years; 57.1% women) with DSM-IV-defined GAD were randomly assigned to placebo (n=170), duloxetine 20 mg (n=84), duloxetine 60-120 mg (n=158) or venlafaxine XR 75-225 mg (n=169) treatment. Each of the three active treatment groups had significantly greater improvements on HAMA total score from baseline to endpoint compared with placebo (p=0.01-0.001). For the HAMA psychic factor score, both duloxetine treatment arms and venlafaxine XR demonstrated significantly greater improvement compared with placebo (p=0.01-0.001). For the HAMA somatic factor score, the mean improvement in the duloxetine 60-120 mg and venlafaxine XR groups was significantly greater than placebo (p0.05 and p0.01 respectively), whose mean improvement did not differ from the duloxetine 20 mg group (p=0.07). Groups did not differ in study discontinuation rate due to adverse events. CONCLUSIONS: Duloxetine and venlafaxine treatment were each efficacious for improvement of core psychic anxiety symptoms and associated somatic symptoms for adults with GAD.

Pollack MH, Endicott J, Liebowitz M, Russell J, Detke M, Spann M, Ball S, Swindle R. · Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital/Harvard Medical School, Boston, MA 02114, USA. · J Psychiatr Res. · Pubmed #18221755 No free full text.

Abstract: BACKGROUND: Duloxetine, a serotonergic noradrenergic reuptake inhibitor, improved functional outcomes in each of three clinical studies for the treatment of adults with generalized anxiety disorder (GAD). Using comparison norms, the current work describes the clinical relevance of these functional improvements in terms of return to normative functioning and symptom remission. METHODS: Data were pooled at the individual patient level from three double-blind, placebo-controlled trials of duloxetine treatment (9-10 weeks acute therapy, dose ranges 60-120mg). Inclusion/exclusion criteria were consistent across studies, and outcome measures included the Sheehan Disability Scale (SDS), Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), and European Quality of Life 5 Dimensions (EQ-5D). RESULTS: Adult patients (mean age=42.4 years; 65% women) were randomly assigned to duloxetine (N=668) or placebo (N=495). At baseline, the majority of patients were impaired on the SDS global functioning (89%), Q-LES-Q-SF maximum percent (95%), and EQ-5D (76%) scores. On each measure, a greater percentage of duloxetine-treated patients converted from an impaired baseline to a normative endpoint score than did placebo-treated patients (p0.001, all comparisons). Remission defined as a HAMA total score at endpoint of 10, compared with 7, captured a greater proportion of patients who were functionally in remission. CONCLUSIONS: GAD is associated with substantial impairment in functioning and subjective well-being, and patients treated with duloxetine 60-120mg/day, compared with placebo, experienced a greater return to normative functioning. Attention to role functioning and quality of life may refine our definition of remission when using standard symptom measures of anxiety.