Effectiveness and Tolerability of Tomoxetine in Adults With Attention Deficit Hyperactivity Disorder

Spencer, Thomas; Biederman, Joseph; Wilens, Timothy E.; Prince, Jeffry; Hatch, Mary; Jones, Jon; Harding, Margaret; Faraone, Stephen V.; Seidman, Larry

doi:10.1176/ajp.155.5.693

Cited by 291 publications

(181 citation statements)

References 7 publications

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“…Atomoxetine is reported to be highly effective, yet produce few side effects and be devoid of abuse liability (Heil, 2002;Michelson et al, 2001Michelson et al, , 2002Spencer et al, 1998). Atomoxetine is a selective norepinephrine transporter inhibitor with a relatively low affinity for serotonin and dopamine uptake processes and with minimal affinity for other biological binding sites (Bymaster et al, 2002).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Reinforcing Effects of Monoamine Reuptake Inhibitors Under a Concurrent Schedule of Food and I.V. Drug Delivery in Rhesus Monkeys

Gąsior

Bergman

Kallman

et al. 2004

Neuropsychopharmacol

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Most medications prescribed for attention-deficit-hyperactivity disorder are psychomotor stimulants with reinforcing effects in laboratory animals (eg methylphenidate). The present studies were conducted to evaluate the reinforcing effects of the recently approved medication atomoxetine in monkeys trained to 'choose' between automated deliveries of either an i.v. injection or food. Rhesus monkeys were trained to lever-press under concurrent schedules of reinforcement; responses on one lever resulted in an injection of either saline or drug, and responses on the alternative lever resulted in food delivery. Data were collected on four measures: response rates, percentage of total responses occurring on the injection-lever (% ILR), number of injections earned, and number of food pellets earned. Dose-effect functions were determined for cocaine (0.003-0.3 mg/kg/inj), methylphenidate (0.003-0.1 mg/kg/inj), amphetamine (0.003-0.1 mg/kg/inj), atomoxetine (0.01-0.3 mg/kg/inj), and desipramine (0.03-1.0 mg/kg/inj) using a double alternation schedule of saline and drug availability. Results indicate that the distribution of behavior changed according to the drug and dose available for self-injection. Saline availability was typically associated with high rates of food-maintained responding. The % ILR increased from 371% when saline was available to 490% when 40.03 mg/kg/inj of cocaine, methylphenidate or d-amphetamine was available. However, no dose of atomoxetine or desipramine maintained self-administration behavior on the injection-lever. The number of food pellets earned per session decreased as the dose of each drug increased, indicative of behavioral activity with all five drugs. The reinforcing effects of cocaine, methylphenidate, and d-amphetamine in these studies are consistent with previous findings in nonhuman primates and with their documented abuse liability. The absence of reinforcing effects of atomoxetine support the view that, like desipramine, it has no evident abuse potential.

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Section: Introductionmentioning

confidence: 99%

Evaluation of the Reinforcing Effects of Monoamine Reuptake Inhibitors Under a Concurrent Schedule of Food and I.V. Drug Delivery in Rhesus Monkeys

Gąsior

Bergman

Kallman

et al. 2004

Neuropsychopharmacol

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“…17,18 However, the relative efficacy and the relative safety and tolerability of different doses have not been assessed. We hypothesized that atomoxetine would be superior to placebo for the treatment of ADHD and report results of a fixed-dose study of comparing 3 different doses of atomoxetine with placebo.…”

mentioning

confidence: 99%

Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized, Placebo-Controlled, Dose-Response Study

et al. 2001

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ABSTRACT. Objective. Atomoxetine is an investigational, nonstimulant pharmacotherapy being studied as potential treatment for attention-deficit/hyperactivity disorder (ADHD). It is thought to act via blockade of the presynaptic norepinephrine transporter in the brain. We assessed the efficacy of 3 doses of atomoxetine compared with placebo in children and adolescents with ADHD.Methods. A total of 297 children and adolescents who were 8 to 18 years of age and had ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, were randomized to placebo or atomoxetine dosed on a weight-adjusted basis at 0.5 mg/kg/day, 1.2 mg/kg/day, or 1.8 mg/kg/day for an 8-week period. ADHD symptoms, affective symptoms, and social and family functioning were assessed using parent and investigator rating scales.Results. Approximately 71% of children enrolled were male, approximately 67% met criteria for mixed subtype (both inattentive and hyperactive/impulsive symptoms), and the only common psychiatric comorbidity was oppositional defiant disorder (approximately 38% of the sample). At baseline, symptom severity was rated as moderate to severe for most children. At endpoint, atomoxetine 1.2 mg/kg/day and 1.8 mg/kg/day were consistently associated with superior outcomes in ADHD symptoms compared with placebo and were not different from each other. The dose of 0.5 mg/kg/day was associated with intermediate efficacy between placebo and the 2 higher doses, suggesting a graded dose-response. Social and family functioning also were improved in the atomoxetine groups compared with placebo with statistically significant improvements in measures of children's ability to meet psychosocial role expectations and parental impact. Discontinuations as a result of adverse events were <5% for all groups.Conclusion. Among children and adolescents aged 8 to 18, atomoxetine was superior to placebo in reducing ADHD symptoms and in improving social and family functioning symptoms. Atomoxetine was associated with a graded dose-response, and 1.2 mg/kg/day seems to be as effective as 1.8 mg/kg/day and is likely to be the appropriate initial target dose for most patients. Treatment with atomoxetine was safe and well tolerated.

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“…For other children, the symptoms continue and therefore treatments need to be continued into adolescence, and possibly even into adulthood. 2,34 There is a growing evidence base to support the use of methylphenidate and atomoxetine [34][35][36][37][38] in adults with ADHD and the management of ADHD in this age group is included in most current guidelines. 2,3,6 In general, when a child with ADHD turns 18 years old, the treatment should continue as before with periodic assessments and reviews.…”

Section: Use In Special Populationsmentioning

confidence: 99%

Pharmacological treatments for ADHD

Parker¹

2013

Prog Neurol Psychiatry

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Effectiveness and Tolerability of Tomoxetine in Adults With Attention Deficit Hyperactivity Disorder

Abstract: This preliminary study showed that tomoxetine was effective in treating adult ADHD and was well tolerated. These promising results provide support for further studies of tomoxetine over an extended period of treatment.

Cited by 291 publications

References 7 publications

Evaluation of the Reinforcing Effects of Monoamine Reuptake Inhibitors Under a Concurrent Schedule of Food and I.V. Drug Delivery in Rhesus Monkeys

Evaluation of the Reinforcing Effects of Monoamine Reuptake Inhibitors Under a Concurrent Schedule of Food and I.V. Drug Delivery in Rhesus Monkeys

Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized, Placebo-Controlled, Dose-Response Study

Pharmacological treatments for ADHD

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