Research and Clinical Trials on Atomoxetine (Strattera)

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By Dr Greg Mulhauser

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):

Cessation of attention deficit hyperactivity disorder drugs in the young (CADDY) - a pharmacoepidemiological and qualitative study.

Health Technol Assess. 2009 Oct; 13(50): 1-144
Wong I, Asherson P, Bilbow A, Clifford S, Coghill D, Desoysa R, Hollis C, McCarthy S, Murray M, Planner C, Potts L, Sayal K, Taylor E
OBJECTIVES: To estimate the prevalence of attention deficit hyperactivity disorder (ADHD) pharmacological treatment, and its demographic and clinical details, and to estimate the proportion of patients in the target group who stopped ADHD treatment and investigate possible factors for continuation or cessation of treatment. DESIGN: A pharmacoepidemiological study using an automated database and a qualititative study using patient interviews. Part 1 was a pharmacoepidemiological study that provided accurate data on use and cessation of ADHD drugs. Part 2 was an in-depth interview study to investigate the reasons, processes and outcomes of treatment cessation. SETTING: Part 1: primary care using the General Practice Research Database (GPRD). Part 2: secondary and tertiary care paediatric clinics, child and adolescent mental health and adult mental health clinics in London, Nottingham, Dundee and Liverpool. PARTICIPANTS: Part 1: patients were 15-21 years old during the study period (1 January 2001 and 31 December 2004), had at least one prescription for methylphenidate, dexamfetamine or atomoxetine and had at least 1 year of research-standard data available in the GPRD. Part 2: patients fulfilled Part 1 criteria, had a diagnosis of ADHD as detected by a predefined algorithm and had been treated with methylphenidate, dexamfetamine or atomoxetine for at least 1 year. Child and adolescent psychiatrists, adult psychiatrists and paediatricians involved in the treatment of young people with ADHD were also interviewed as part of the study. RESULTS: Part 1: prevalence of prescribing averaged across all ages increased eightfold, from 0.26 per 1000 patients in 1999 to 2.07 per 1000 patients in 2006. The increase in prevalence in the younger patients was less evident in the older patients. Prevalence in 15-year-old males receiving a study drug prescription increased from 1.32 per 1000 patients in 1999 to 8.31 per 1000 patients in 2006, whereas the prevalence in 21-year-olds rose from 0 per 1000 patients in 1999 to 0.43 per 1000 patients in 2006. Survival analysis showed that the rate of treatment cessation largely exceeded the estimated rate of persistence of ADHD. The reduction in prescribing was most noticeable between 16 and 17 years of age. Kaplan-Meier analysis showed that approximately 18% of patients restarted treatment if they had stopped treatment after the age of 15. Patients who restarted treatment were more likely to restart within the first year following treatment cessation. Part 2: the Child Health and Illness Profile (CHIP) was chosen as the quality of life questionnaire for the Part 2 study because the CHIP-CE scale has been validated in children with ADHD in the UK. Because of the age range of participants, the adolescent version (CHIP-AE) was administered to patients after interview. Of the 15, a total of nine patients finished the questionnaire. Interviews showed that although some young people felt able to cope after stopping medication, others felt the need to restart to control symptoms. Some patients had difficulty re-engaging with services and clinicians recognised the lack of services for young adults. Patients continuing on treatment considered cessation as an option for the future, but were concerned about the process of stopping and its impact on behaviour. CONCLUSIONS: Part 1 study demonstrated that the prevalence of prescribing by GPs to patients with ADHD dropped significantly from age 15 to 21. The fall in prescribing was greater than the reported age-related decrease in symptoms, raising the possibility that treatment is prematurely discontinued in some young adults where ADHD symptoms persist. Part 2 of the study identified that some young adults had difficulty in obtaining treatment after discharge from paediatric services. Future work should include randomised placebo-controlled trials into long-term treatment with stimulants, particularly methylphenidate.

Atomoxetine as an adjunct therapy in the treatment of co-morbid attention-deficit/hyperactivity disorder in children and adolescents with bipolar I or II disorder.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 547-51
Chang K, Nayar D, Howe M, Rana M
INTRODUCTION: Atomoxetine has been proposed to be effective for treating co-morbid attention-deficit/hyperactivity disorder (ADHD) in children with bipolar disorder (BPD) without destabilizing mood. We conducted an 8-week, open label study to study the efficacy and tolerability of adjunct atomoxetine in euthymic children and adolescents with BPD and ADHD. METHODS: We evaluated 12 youth aged 6-17 years (mean = 11.3 years; 7 males) with a diagnosis of BPD I or II and ADHD. Subjects were euthymic at baseline and taking at least one mood stabilizer or antipsychotic. Primary outcome measure was the ADHD Rating Scale-IV (ADHD-RS-IV) (response = 25% decrease; remission = 40% decrease). Secondary outcome measures were change in Young Mania Rating Scale (YMRS) and Children's Depression Rating Scale (CDRS). RESULTS: In primary outcome criteria, 8 (67%) were responders and 6 (50%) were remitters by ADHD-RS criteria. There was a significant decrease in ADHD-RS scores over the study (p < 0.0001; Cohen d = 2.18, effect size = 0.73). YMRS and CDRS scores did not change significantly from baseline to week 8. No subjects experienced a manic or mixed episode during the study, but 2 subjects were discontinued early due to worsening of mood symptoms. CONCLUSIONS: We found atomoxetine to be efficacious in treating symptoms of ADHD in children and adolescents with BPD taking mood stabilizers or antipsychotics. It is unclear whether symptomatic worsening of 2 subjects was due to atomoxetine or the natural course of illness. Placebo-controlled studies are needed to clarify the role of atomoxetine in this population.

An open study of adjunct OROS-methylphenidate in children who are atomoxetine partial responders: II. Tolerability and pharmacokinetics.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 493-9
Hammerness P, Georgiopoulos A, Doyle RL, Utzinger L, Schillinger M, Martelon M, Brodziak K, Biederman J, Wilens TE
OBJECTIVE: The aim of this study was to evaluate the tolerability of adding OROS methylphenidate (MPH) to children who are partial responders to atomoxetine (ATMX) in the treatment of attention-deficit/hyperactivity disorder (ADHD). METHODS: This was a two-phase, 7-week, open study in children aged 6-17 years. Phase 1 initiated ATMX for a minimum of 4 weeks. Phase 2 entered partial responders to ATMX and added OROS MPH to their regimen. Safety was assessed using blood pressure and heart rate measurements, electrocardiogram readings, AEs, laboratories, and ATMX levels. RESULTS: Fifty subjects who were partial responders to ATMX received the combination therapy, with 41 subjects completing the entire protocol. As reported elsewhere (Wilens et al., 2009 ), OROS MPH added to partial responders of ATMX was accompanied by a 40% reduction in the ADHD rating scale score and improvements in executive functioning. However, the combination of ATMX plus OROS MPH was associated with greater rates of insomnia, irritability, and loss of appetite compared to ATMX alone. A small significant increase in diastolic blood pressure was observed during adjunctive OROS MPH, with no clinically meaningful changes in electrocardiogram (ECG) parameters during the study. ATMX levels and liver function tests did not significantly change during the combination treatment. CONCLUSION: Adjunct OROS MPH in ATMX partial responders yielded an additive adverse effect burden in this short-term study. Further controlled research with larger samples of children is warranted.

An open study of adjunct OROS-methylphenidate in children and adolescents who are atomoxetine partial responders: I. Effectiveness.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 485-92
Wilens TE, Hammerness P, Utzinger L, Schillinger M, Georgiopoulous A, Doyle RL, Martelon M, Brodziak K
OBJECTIVE: This study evaluated the effectiveness of adding OROS methylphenidate (MPH) to children who are partial responders to atomoxetine (ATMX) in the treatment of attention-deficit/hyperactivity disorder (ADHD). METHODS: This is a two-phase, 7-week, open study in children aged 6-17 years. Phase I initiated ATMX for a minimum of 4 weeks. Phase II entered partial responders to ATMX and added up to 54 mg of OROS MPH to their regimen. Subjects were assessed on multiple outcomes, including ADHD, executive functioning, and adverse effects. All analyses were intent to treat, with last observation carried forward. RESULTS: Fifty subjects who were partial responders to ATMX were treated with the combination therapy, with 41 subjects completing the entire protocol. There was a 40% reduction in their ADHD Rating Scale from the start of phase II through the end of study (from 21.14 +/- 9.9 to 12.8 +/- 9.7, t = 6.5, p < 0.0001). In addition, there was a clinically significant reduction in the Clinical Global Index of ADHD severity from moderate to mild ADHD (start of phase II, 3.7; end of phase II, 2.7, 27%, t = 6.5, p < 0.0001), as well as improvements in executive functioning. CONCLUSION: These results suggest that OROS MPH added to the regimen of partial responders to ATMX improves ADHD and executive functioning, necessitating further controlled trials.

Retrospective safety analysis of atomoxetine in adult ADHD patients with or without comorbid alcohol abuse and dependence.

Am J Addict. 2009 Sep-Oct; 18(5): 393-401
Adler L, Wilens T, Zhang S, Durell T, Walker D, Schuh L, Jin L, Feldman P, Trzepacz P
This post hoc analysis compared the safety of atomoxetine treatment of ADHD in adults with or without comorbid alcohol abuse/dependence. Study completion rates in patients receiving atomoxetine were comparable between heavy drinkers (60.9%) and patients with no alcohol-use disorder (71.0%) but lower in nonheavy drinkers (35.7%); however, there was no significant difference in discontinuation rates due to adverse events or lack of efficacy among these groups. Alcohol-use disorder patients, especially heavy drinkers, generally experienced the greatest frequency of treatment-emergent adverse events in both the atomoxetine and placebo groups. Vital signs and measures of hepatic function were not significantly different among the 3 drinking status groups taking atomoxetine.

 

This page was last reviewed by Dr Greg Mulhauser, Monday, 1 June 2009.

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