Research and Clinical Trials on Atomoxetine (Strattera)

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).

• Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
  Status: Recruiting, Condition Summary: Attention Deficit Hyperactivity Disorder; Dyslexia
• Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
  Status: Recruiting, Condition Summary: Fetal Alcohol Syndrome; Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD)
• Atomoxetine and Parent Management Training in Treating Children With Autism and Symptoms of Attention Deficit Disorder With Hyperactivity
  Status: Recruiting, Condition Summary: Autism; Attention Deficit Disorder With Hyperactivity
• Atomoxetine, Placebo and Parent Management Training in Autism
  Status: Recruiting, Condition Summary: Autism; Pervasive Developmental Disorder Not Otherwise Specified; Asperger's Disorder; Attention Deficit Hyperactivity Disorder
• Atomoxetine for the Treatment of Cannabis Dependence
  Status: Completed, Condition Summary: Cannabis Dependence
• Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
  Status: Completed, Condition Summary: Attention Deficit Hyperactivity Disorder
• Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD
  Status: Completed, Condition Summary: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
• Effects of Atomoxetine on Brain Activation During Attention and Reading Tasks in Patients With ADHD & Comorbid Dyslexia
  Status: Recruiting, Condition Summary: Attention Deficit Hyperactivity Disorder; Dyslexia
• Long-Term, Open Label Atomoxetine Study
  Status: Active, not recruiting, Condition Summary: Attention Deficit Hyperactivity Disorder
• Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder
  Status: Completed, Condition Summary: Generalized Social Anxiety Disorder
• Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
  Status: Completed, Condition Summary: Attention Deficit Disorder With Hyperactivity
• Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
  Status: Recruiting, Condition Summary: Traumatic Brain Injury
• Effects of Atomoxetine Treatment in Humans
  Status: Active, not recruiting, Condition Summary: Stress
• A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia
  Status: Completed, Condition Summary: Schizophrenia; Schizoaffective Disorder
• Atomoxetine and Huntington's Disease
  Status: Active, not recruiting, Condition Summary: Huntington Disease; Chorea

 

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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):

Mortality associated with attention-deficit hyperactivity disorder (ADHD) drug treatment: a retrospective cohort study of children, adolescents and young adults using the general practice research database.

Drug Saf. 2009; 32(11): 1089-96
McCarthy S, Cranswick N, Potts L, Taylor E, Wong IC
BACKGROUND: Following reports of sudden death in patients taking medication to treat attention-deficit hyperactivity disorder (ADHD), this study aimed to identify cases of death in patients prescribed stimulants and atomoxetine and to determine any association between these and sudden death. METHOD: The UK General Practice Research Database (GPRD) was used to identify patients aged 2-21 years from 1 January 1993 to 30 June 2006 with a prescription for methylphenidate, dexamfetamine or atomoxetine. Patients were followed from the date of first prescription until whichever came first: date of death, transferred-out date, age >21 years or end of the study period. RESULTS: From a cohort of 18 637 patient-years, seven patients died. Cause of death was obtained for six of the patients. None were deemed to be cases of sudden death. Compared with a general population rate of sudden death in the literature, the worst-case scenario of one case of sudden death gave an incident rate ratio of 1.63 (95% CI 0.04, 9.71). Although it was not the primary outcome of the study, following reports of suicide in the cohort the standardized mortality ratio (SMR) of suicide was calculated. Due to differences in the definition of suicide used for children and adults, patients were categorized into two age groups: 11-14 years and 15-21 years. The SMR for suicide for patients aged 11-14 years was 161.91 (95% CI 19.61, 584.88). The SMR for suicide for patients aged 15-21 years was 1.84 (95% CI 0.05, 10.25). CONCLUSION: This study demonstrated no increase in the risk of sudden death associated with stimulants or atomoxetine. However, an increased risk of suicide was seen. Although we cannot exclude that the medications may contribute to the increased risk of suicide, there are other factors such as depression and antisocial behaviour that frequently co-exist with ADHD, which can also predispose to teenage suicide. Clinicians should identify patients at increased risk of cardiovascular events and identify those patients at increased risk of suicide, particularly males with co-morbid conditions, and monitor them appropriately.

Gateways to clinical trials.

Methods Find Exp Clin Pharmacol. 2009 Jul-Aug; 31(6): 397-417
Tomillero A, Moral MA
[90Y-DOTA-Tyr3]octreotate, Abatacept, ABT-888, ACE-011, Adefovir dipivoxil, Alosetron hydrochloride, Aminolevulinic acid methyl ester, Amlodipine, Apaziquone, Aripiprazole, AS-101, Atomoxetine hydrochloride, Atrasentan, Azacitidine; Bevacizumab, Biphasic insulin aspart, Bortezomib, Bosentan, Brivanib alaninate; CERE-120, Cetuximab, Ciclesonide, Cinacalcet hydrochloride, Combretastatin A-1 phosphate, Conatumumab, CT-322; Dabigatran etexilate, Darunavir, Deforolimus, Desloratadine, Doripenem, Doxorubicin eluting beads, Duloxetine hydrochloride, Dutasteride; Escitalopram oxalate, Eszopiclone, Etravirine, Exenatide, Ezetimibe, Ezetimibe/simvastatin; Fluticasone furoate, Fondaparinux sodium; Gabapentin enacarbil, Ghrelin (human), Golimumab; IC-51, IDM-2, JX-594; Lidocaine/prilocaine, Liraglutide, Lopinavir, Lopinavir/ritonavir, Lumiracoxib; Men ACWY, MxdnG1; Naproxcinod; OBP-301, Omalizumab; Paclitaxel nanoparticles, Pasireotide, Pazopanib hydrochloride, Pegaptanib octasodium, Peginterferon alfa-2a, Pegvisomant, Pemetrexed disodium, Pimecrolimus, Prasterone, Pregabalin; Raclopride, Ranelic acid distrontium salt, Ranibizumab, RB-006, Recombinant human relaxin H2, REG1, Regadenoson, Reximmune-C, Rilonacept; Saxagliptin, SCH-697243, Solifenacin succinate, Sorafenib; Tadalafil, Tapentadol hydrochloride, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate/emtricitabine, Tipifarnib, Tolvaptan; Vardenafil hydrochloride hydrate, Vicriviroc, Volociximab, Vorinostat; WB-1001; Yttrium 90 (90Y) ibritumomab tiuxetan.

Atomoxetine may improve methylphenidates' efficacy in treatment of ADHD?

Psychiatr Danub. 2009 Sep; 21(3): 330
Niederhofer H

Validation of the Adult ADHD Investigator Symptom Rating Scale (AISRS).

J Atten Disord. 2009 Sep 30;
Spencer TJ, Adler LA, Qiao M, Saylor KE, Brown TE, Holdnack JA, Schuh KJ, Trzepacz PT, Kelsey DK
Objective: Validation of the Adult ADHD Investigator Symptom Rating Scale (AISRS) that measures aspects of ADHD in adults. Method: Psychometric properties of the AISRS total and AISRS subscales are analyzed and compared to the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARSInv: SV) and the Clinical Global Impression-ADHD-Severity Scale using data from a placebo-controlled 6-month clinical trial of once-daily atomoxetine. Results: The AISRS has high internal consistency, good convergent, and discriminant validities; modest divergent validity; and small ceiling and floor effects (

Evaluation of atomoxetine for first-line treatment of newly diagnosed, treatment-naïve children and adolescents with attention deficit/hyperactivity disorder.

Curr Med Res Opin. 2009 Nov; 25(11): 2745-54
Montoya A, Hervas A, Cardo E, Artigas J, Mardomingo MJ, Alda JA, Gastaminza X, García-Polavieja MJ, Gilaberte I, Escobar R
OBJECTIVE: To test the hypothesis that first-line treatment with atomoxetine provides superior efficacy than placebo for up to 12 weeks in improving the symptoms of Attention Deficit/Hyperactivity Disorder (ADHD). RESEARCH DESIGN AND METHODS: This double-blind, randomized, placebo-controlled, parallel clinical trial included 151 treatment-naïve children (n = 113) and adolescents (n = 38) with newly diagnosed (< or =3 months) ADHD. Atomoxetine dose was uptitrated from 0.5 to 1.2 mg/kg/day after two weeks. Outcome assessments included the ADHD Rating Scale-IV-Parent-reported Investigator-rated (ADHDRS-IV-Parent:Inv), the Clinical Global Impression of Severity of ADHD (CGI-ADHD-S), and the incidence of adverse events. Mixed-model repeated measures analysis was used to compare scale score changes between groups. Clinical trial registration: Trial registered at www.clinicaltrials.gov (study internal code: B4Z-XM-LYDM, identifier: NCT00191945). RESULTS: Most patients were male (79.2%), of caucasian origin (96.0%) and severely ill (72.5%). Their mean age was 10.3 years. Atomoxetine-treated patients showed greater reductions from baseline to week 12 of total ADHDRS-IV-Parent:Inv score than placebo-treated patients (least square mean difference: -7.9 [95% CI: -11.0 to -4.8], corresponding to a large effect size of 0.8). Between-group mean differences increased progressively with treatment exposure from week 6 to 12 (-2.7 [-4.9 to -0.6] for total and -1.6 [-2.9 to -0.3] for inattention scores). At the end of the study, 50% of atomoxetine-treated patients (14% with placebo) showed a reduction > or =40% in total ADHDRS-IV-Parent:Inv score, and only 29% (46% with placebo) were severely ill (by CGI-ADHD-S). Treatment-related adverse events were significantly more frequent with atomoxetine (65.0%) than with placebo (37.3%), the most frequent being decreased appetite and somnolence. Only one case of decreased appetite was rated as severe. No patient discontinued treatment because of adverse events. CONCLUSIONS: A continued improvement of symptoms is expectable until 12 weeks in treatment-naïve ADHD patients treated with atomoxetine as first-line medication. Chief limitations are the small, national sample size and the absence of data beyond the 12-week time-point.