Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorder

Lenard A. Adler, Michael Liebowitz, William Kronenberger, Meihua Qiao, Richard Rubin, Millie Hollandbeck, Ahmed Deldar, Kory Schuh, Todd Durell

Research output: Contribution to journalArticle

104 Citations (Scopus)

Abstract

Background: To evaluate the effect of atomoxetine (ATX) on attention-deficit/ hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. Methods: Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40-100 mg ATX (n = 224) or placebo (n = 218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O- S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. Results: ATX mean change (-8.7±10.0) from baseline (29.6±10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (-5.6±10.2) from baseline (31.2 ± 9.4; Po>001). ATX mean change (-22.9 ± 25.3) from baseline (85.3 ±23.6) on LSAS Total score was significant compared to placebo mean change (-14.4 ± 20.3) from baseline (82.1±21.3; P> 001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATXat every time point throughout the study (P values ≥ 012). Mean changes in CGI-O-S, STAI-Trait Anxiety scores, and AAQoL Total score were significantly greater for ATX compared to placebo. Mean change for both groups on STAI-State Anxiety scores was comparable. Improvement on SAS for ATX compared to placebo was not significant. Rates ofinsomnia, nausea, dry mouth, and dizziness were higher with ATX than with placebo. Discontinuation rates due to treatment- emergent adverse events were similar between groups. Conclusions: ATX monotherapy effectively improved symptoms ofADHD and comorbid social anxiety disorder in adults and was well tolerated.

Original languageEnglish
Pages (from-to)212-221
Number of pages10
JournalDepression and Anxiety
Volume26
Issue number3
DOIs
StatePublished - Mar 2009

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Attention Deficit Disorder with Hyperactivity
Anxiety
Placebos
Research Personnel
Therapeutics
Equipment and Supplies
Self Report
Quality of Life
Social Adjustment
Social Phobia
Atomoxetine Hydrochloride
Dizziness
Double-Blind Method
Nausea
Mouth
Safety

Keywords

  • ADHD
  • Adults
  • Atomoxetine
  • Social anxiety disorder

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorder. / Adler, Lenard A.; Liebowitz, Michael; Kronenberger, William; Qiao, Meihua; Rubin, Richard; Hollandbeck, Millie; Deldar, Ahmed; Schuh, Kory; Durell, Todd.

In: Depression and Anxiety, Vol. 26, No. 3, 03.2009, p. 212-221.

Research output: Contribution to journalArticle

Adler, LA, Liebowitz, M, Kronenberger, W, Qiao, M, Rubin, R, Hollandbeck, M, Deldar, A, Schuh, K & Durell, T 2009, 'Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorder', Depression and Anxiety, vol. 26, no. 3, pp. 212-221. https://doi.org/10.1002/da.20549
Adler, Lenard A. ; Liebowitz, Michael ; Kronenberger, William ; Qiao, Meihua ; Rubin, Richard ; Hollandbeck, Millie ; Deldar, Ahmed ; Schuh, Kory ; Durell, Todd. / Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorder. In: Depression and Anxiety. 2009 ; Vol. 26, No. 3. pp. 212-221.
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abstract = "Background: To evaluate the effect of atomoxetine (ATX) on attention-deficit/ hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. Methods: Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40-100 mg ATX (n = 224) or placebo (n = 218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O- S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. Results: ATX mean change (-8.7±10.0) from baseline (29.6±10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (-5.6±10.2) from baseline (31.2 ± 9.4; Po>001). ATX mean change (-22.9 ± 25.3) from baseline (85.3 ±23.6) on LSAS Total score was significant compared to placebo mean change (-14.4 ± 20.3) from baseline (82.1±21.3; P> 001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATXat every time point throughout the study (P values ≥ 012). Mean changes in CGI-O-S, STAI-Trait Anxiety scores, and AAQoL Total score were significantly greater for ATX compared to placebo. Mean change for both groups on STAI-State Anxiety scores was comparable. Improvement on SAS for ATX compared to placebo was not significant. Rates ofinsomnia, nausea, dry mouth, and dizziness were higher with ATX than with placebo. Discontinuation rates due to treatment- emergent adverse events were similar between groups. Conclusions: ATX monotherapy effectively improved symptoms ofADHD and comorbid social anxiety disorder in adults and was well tolerated.",
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AU - Qiao, Meihua

AU - Rubin, Richard

AU - Hollandbeck, Millie

AU - Deldar, Ahmed

AU - Schuh, Kory

AU - Durell, Todd

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N2 - Background: To evaluate the effect of atomoxetine (ATX) on attention-deficit/ hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. Methods: Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40-100 mg ATX (n = 224) or placebo (n = 218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O- S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. Results: ATX mean change (-8.7±10.0) from baseline (29.6±10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (-5.6±10.2) from baseline (31.2 ± 9.4; Po>001). ATX mean change (-22.9 ± 25.3) from baseline (85.3 ±23.6) on LSAS Total score was significant compared to placebo mean change (-14.4 ± 20.3) from baseline (82.1±21.3; P> 001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATXat every time point throughout the study (P values ≥ 012). Mean changes in CGI-O-S, STAI-Trait Anxiety scores, and AAQoL Total score were significantly greater for ATX compared to placebo. Mean change for both groups on STAI-State Anxiety scores was comparable. Improvement on SAS for ATX compared to placebo was not significant. Rates ofinsomnia, nausea, dry mouth, and dizziness were higher with ATX than with placebo. Discontinuation rates due to treatment- emergent adverse events were similar between groups. Conclusions: ATX monotherapy effectively improved symptoms ofADHD and comorbid social anxiety disorder in adults and was well tolerated.

AB - Background: To evaluate the effect of atomoxetine (ATX) on attention-deficit/ hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. Methods: Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40-100 mg ATX (n = 224) or placebo (n = 218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O- S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. Results: ATX mean change (-8.7±10.0) from baseline (29.6±10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (-5.6±10.2) from baseline (31.2 ± 9.4; Po>001). ATX mean change (-22.9 ± 25.3) from baseline (85.3 ±23.6) on LSAS Total score was significant compared to placebo mean change (-14.4 ± 20.3) from baseline (82.1±21.3; P> 001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATXat every time point throughout the study (P values ≥ 012). Mean changes in CGI-O-S, STAI-Trait Anxiety scores, and AAQoL Total score were significantly greater for ATX compared to placebo. Mean change for both groups on STAI-State Anxiety scores was comparable. Improvement on SAS for ATX compared to placebo was not significant. Rates ofinsomnia, nausea, dry mouth, and dizziness were higher with ATX than with placebo. Discontinuation rates due to treatment- emergent adverse events were similar between groups. Conclusions: ATX monotherapy effectively improved symptoms ofADHD and comorbid social anxiety disorder in adults and was well tolerated.

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