Research and Clinical Trials on Atomoxetine (Strattera)

By Dr Greg Mulhauser
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This list of current clinical research trials on Atomoxetine (Strattera) is followed by a short set of abstracts from the most recent research articles published on the drug.

Article Contents

Atomoxetine (Strattera) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Atomoxetine (Strattera).

 

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Current Research Literature on Atomoxetine (Strattera)

Here are abstracts for some of the latest research articles to have appeared on Atomoxetine (Strattera):

Does atomoxetine increase the risk of aggression and hostility in children with attention deficit hyperactivity disorder (ADHD)?

Arch Dis Child. 2008 May 2;
Banerjee S, Ayyash HF
Clinical bottom line 1. Aggression and/or hostility can be associated with ADHD (Grade B). 2. Present evidence does not suggest aggression/hostility with atomoxetine compared with methylphenidate or placebo, although it can not be completed ruled out (Grade A).

Long-Term, Open-Label Safety and Efficacy of Atomoxetine in Adults With ADHD: Final Report of a 4-Year Study.

J Atten Disord. 2008 Apr 30;
Adler LA, Spencer TJ, Williams DW, Moore RJ, Michelson D
Objective: Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment. Method: Results were derived from the study of 384 patients (125 patients remaining in the open-label trial since the interim report), receiving up to 221 weeks of treatment. Primary efficacy measure was the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom score. Adverse events and vital signs were assessed. Results: CAARS-Inv:SV Total ADHD Symptom scores decreased 30.2% (p < .001) during treatment. Similar, significant decreases were noted for the secondary efficacy measures, including the Sheehan Disability Scale Total score, which improved 25.3% (p < .001). Adverse events consisted primarily of pharmacologically (noradrenergic) expected effects. Conclusions: Results of this open-label study support the long-term efficacy, safety, and tolerability of atomoxetine for the treatment of adult ADHD. (J. of Att. Dis. 2008; XX(X) xx-xx).

Tic exacerbation and precipitation during atomoxetine treatment in two children with attention-deficit hyperactivity disorder.

Int J Psychiatry Med. 2007; 37(4): 415-24
Párraga HC, Párraga MI, Harris DK
Stimulants have been the mainstay of treatment for children with Attention-deficit/hyperactivity Disorder (ADHD). However, stimulants have been controversially purported to precipitate and exacerbate tics. Atomoxetine, a selective norepinephrine inhibitor, was introduced as a safe non-stimulant alternative treatment for ADHD children with comorbid tics or TS. We are presenting two children with ADHD, in which atomoxetine, at relatively low doses, exacerbated and precipitated tics. The diagnoses of ADHD and tic disorder were based on clinical observations and standardized rating scales. Case 1, an 8-year-old boy, had history of stimulant-induced tics. This child was placed on atomoxetine reported to be safe for patients with tics. This patient's tic control was adequate prior to atomoxetine treatment. However, while on atomoxetine, the patient promptly experienced tic exacerbation. Case 2, a 6-year-old boy, had no previous history of stimulant therapy and was receiving citalopram due to a comorbid anxiety disorder. Atomoxetine was initiated for the treatment of ADHD with improvement in the ADHD symptoms. But, upon a mild dose increase, the patient presented tic precipitation consisting primarily of neck twitches. Both cases experienced a decrease in tic activity when atomoxetine was discontinued, but tics did not fully resolve, causing psychosocial disturbance. Atypical neuroleptics were used with good results. Periodic assessments of the need for continued neuroleptic treatment were emphasized. These two children exemplify atomoxetine's potential to exacerbate and precipitate tics in children with ADHD. Independent controlled studies are needed to determine if atomoxetine should be used in children with ADHD and comorbid tic disorders or TS.

Development of tics in a thirteen-year-old male following atomoxetine use.

CNS Spectr. 2008 Apr; 13(4): 301-3
Sears J, Patel NC
Tics and Tourette syndrome are common comorbidities of patients diagnosed with attention-deficit/hyperactivity disorder (ADHD). One of the mainstay pharmacologic therapies for ADHD has been stimulants. However, this class of drugs has been associated with tic exacerbations, thus limiting their utility in this patients subgroup. Atomoxetine has been explored as an alternative treatment as one of the few non-stimulants available to treat ADHD. Early data identifies atomoxetine's influence on Tourette symptomatology to be not merely equivocal but potentially suppressive in the manifestation of tics. There are, however, case studies describing patients experiencing recurrences of tics following treatment with atomoxetine. We present a unique case of a patient, without any prior history of a movement disorder, who developed tics following a single dose of atomoxetine that did not improve until interventional therapy was initiated.

Atomoxetine treatment of adults with ADHD and comorbid alcohol use disorders.

Drug Alcohol Depend. 2008 Apr 8;
Wilens TE, Adler LA, Weiss MD, Michelson D, Ramsey JL, Moore RJ, Renard D, Brady KT, Trzepacz PT, Schuh LM, Ahrbecker LM, Levine LR,
OBJECTIVE: Adults with attention-deficit/hyperactivity disorder (ADHD) have higher rates of alcohol and drug use disorders than adults without ADHD. The study aim was to determine if atomoxetine was superior to placebo in improving ADHD and alcohol use in recently abstinent adults with ADHD and comorbid alcohol use disorder. METHODS: Adults with DSM-IV diagnoses of ADHD and alcohol abuse and/or dependence were abstinent from alcohol at least 4 days (maximum 30 days) before study randomization. Participants received atomoxetine (25-100mg daily) or placebo for 12 weeks. ADHD symptoms were assessed using ADHD Investigator Symptom Rating Scale (AISRS) total score. Time-to-relapse to heavy alcohol use was analyzed using a 2-sided log-rank test based on Kaplan-Meier estimates and cumulative heavy drinking events over time were evaluated post hoc with recurrent-event analysis. RESULTS: Subjects received atomoxetine (n=72) or placebo (n=75) and 80 subjects completed the 12-week double-blind period (n=32 and 48, respectively). ADHD symptoms were significantly improved in the atomoxetine cohort compared to placebo (AISRS total score mean [S.D.], atomoxetine: -13.63 [11.35], P

 

This page was last reviewed by Dr Greg Mulhauser, Tuesday, 22 April 2008.

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