Tomoxetine for Adult ADHD
From MindLinc Wiki
Bottom line: Tomoxetine may be a beneficial drug for adult ADHD, but better studies need to be done.
Clinical Question: A 34-year-old white female appears to have ADHD. She does not want to take methylphenidate or desipramine. What therapy can be offered to her as an alternative?
Background:
- Some follow-up studies have suggested that ADHD in childhood/adolescence continues into adulthood in 10-60%. Its persistence is associated with a myriad of psychosocial pathology.
- Current treatments have their limitations (methylphenidate - abusable, short acting; desipramine - wide range of adverse effects).
- Tomoxetine is a highly selective noradrenergic reuptake inhibitor with little affinity for other systems (muscarinic, cholinergic, histamine, etc). Little effect on cardiac conduction/ function.
- Because of its limited spectrum of adverse effects/ abuse potential, tomexetine might be beneficial in ADHD.
Methods: A placebo controlled, double blind crossover study.
3-week treatment periods with one-week washout in between.
Dose of Tomoxetine - 40mg/day by wk 1, 40mg bid by wk 2, and maintained if no adverse effects. Average dose for tomoxetine was 76mg/day by week 3.
Exclusion Criteria - chronic mental disorders, MR, ETOH, pregnancy, active psychiatric 22 outpatients - between 19-60 years of age (mean age = 34, sd = 9)
Inclusion - DSM IIIR criteria met by the age of 7 as well as having chronic features, reporting detriment from.
Patients - 13 patients had at least one lifetime co morbid psychiatric disorder. Only 2 had current ratings of depression or anxiety that were severe. 20 patients had family hx of ADHD. 9 patients needed tutoring in school, 6 needed to repeat
Scales/tests - ADHD rating scale, Ham D (depression and anxiety), Beck.Wisconsin Card Sorting, Rey- Osterrieth, Stroop test, auditory Continuous Performance Test.
Blinding: Not explained
Responders: 30% reduction in symptoms on ADHD rating scale.
Analysis: McNemar, Wilcoxon, t test given continuous data. Random effects model used, cross sectional time series model.
Validity
- Randomization - ?
- Follow up of patients sufficiently long and complete?
- Were all patients analyzed in the groups to which they were randomized? Yes
- Were the groups similar at the start of the trial? Yes
- Were groups treated equally, apart from the experimental therapy?
Results:
1. One Dropout due to anxiety,. irritability during second week of tomoxetine tx.
| Drug | Mean Score | SD | End Score | SD |
|---|---|---|---|---|
| Tomoxetine | 30 | 6.7 | 21.4 | 10.1 (p= 0.001) |
| Placebo | 29.4 | 6.3 | 29.7 | 8.8 |
2. Hedges G (Effect Size) - 0.85 (CI - 1.48 to 0.22).
3. Odds Ratio - 4.5
4. Using pre-established 30% improvement criteria, 11 of 21 showed improvement with Tomoxetine, vs 2 with placebo (52.3% vs. 9.5%, no intention to treat).
5. NNT = 2.44 (using all 22 patients).
6. Adverse Effects = Insomnia, anxiety in less than 3 patients.
Comments: Promising Study, but too much fuzzy math given crossover design and lack of follow-up. Good pilot type study, however.
