ABSTRACT
The objective of the study was to compare the efficacy and tolerability of once-daily atomoxetine (< or =1.8 mg/(kg day) with those of placebo in children and adolescents (aged 6-16 years) with attention-deficit/hyperactivity disorder [ADHD (DSM-IV)]. This randomized, placebo-controlled, double-blind trial was conducted in Russia. The primary efficacy measure was baseline-to-end point changes in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) total score. Tolerability measures included treatment-emergent signs and symptoms (TESS), laboratory values and weight. Compared with patients in the placebo group (n = 33), patients treated with atomoxetine (n = 72) with a mean final dose of 1.4 mg/kg showed significantly greater improvement in ADHDRS-IV-Parent:Inv total score (least-squares mean: atomoxetine, -15.8; placebo, -11.4; p = 0.013). The most common TESS in the atomoxetine group included anorexia [atomoxetine, n = 13 (18.1%); placebo, n = 2 (6.1%)], somnolence, n = 11 versus n = 3 (15.3% vs. 9.1%, respectively), abdominal pain n = 9 versus n = 1 (12.5% vs. 3.0%, respectively) and nausea, n = 8 versus n = 1 (11.1% vs. 3.0%, respectively). Seven patients in the atomoxetine group and two in the placebo group experienced clinically important weight loss during the study (> or =7% from baseline; mean change, kg: atomoxetine, -0.6; placebo, 0.1; p = 0.032). Atomoxetine is efficacious in improving ADHD symptoms in children and adolescents. Atomoxetine treatment may be associated with a numerically higher incidence of anorexia, somnolence, abdominal pain and nausea, as well as statistically greater losses in body weight.
Subject(s)
Adrenergic Uptake Inhibitors/therapeutic use , Attention Deficit Disorder with Hyperactivity/drug therapy , Propylamines/therapeutic use , Abdominal Pain/chemically induced , Adolescent , Adrenergic Uptake Inhibitors/adverse effects , Analysis of Variance , Anorexia/chemically induced , Atomoxetine Hydrochloride , Attention Deficit Disorder with Hyperactivity/diagnosis , Child , Double-Blind Method , Female , Humans , Nausea/chemically induced , Parents , Propylamines/adverse effects , Psychiatric Status Rating Scales/statistics & numerical data , Russia , Sleep/drug effects , Treatment Outcome , Weight Loss/drug effectsABSTRACT
OBJECTIVE: Some experimental and observational data suggest a role of estrogen in depression. Raloxifene is a selective estrogen receptor modulator (SERM) approved for the prevention and treatment of postmenopausal osteoporosis. Its influence on mood in postmenopausal women has not been fully established. Thus, we investigated the effect of raloxifene on mood. METHODS: In a randomized double-blind osteoporosis prevention study, the action of raloxifene on mood was assessed in a subgroup of non-depressed postmenopausal women (mean age: 58.9 years) receiving raloxifene 60 mg/day (n=18) or placebo (n=18). The Hamilton Depression Rating Scale (HDRS) was applied to evaluate mood 3 and 12 months following treatment. RESULTS: Baseline HDRS scores were not different among treatment groups. Overall scores decreased from baseline at 3 and 12 months in the raloxifene group (PSubject(s)
Depression/psychology
, Osteoporosis, Postmenopausal/prevention & control
, Raloxifene Hydrochloride/therapeutic use
, Selective Estrogen Receptor Modulators/therapeutic use
, Administration, Oral
, Depression/chemically induced
, Double-Blind Method
, Female
, Humans
, Middle Aged
, Postmenopause/psychology
, Raloxifene Hydrochloride/administration & dosage
, Raloxifene Hydrochloride/adverse effects
, Selective Estrogen Receptor Modulators/administration & dosage
, Selective Estrogen Receptor Modulators/adverse effects
, Surveys and Questionnaires