Paxil Fails to Improve Children's MDD
Paroxetine was no more effective than a placebo in reducing the symptoms of major depressive disorder in a population that, for the first time, included patients younger than 12 years, reported Dr. Graham J. Emslie of the University of Texas, Dallas, and his colleagues.
Overall, the average change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) was −22.58 points in patients who took paroxetine (Paxil) and −23.38 in a placebo group.
The randomized, double-blind, multicenter study of the effectiveness of paroxetine included an intent-to-treat population of 203 children aged 7–17 years who met the DSM-IV diagnostic criteria for major depressive disorder (J. Am. Acad. Child Adolesc. Psychiatry 2006;45:709–19).
The patients received either 10–50 mg/kg paroxetine daily or placebo for 8 weeks. The average age at diagnosis was 10 years, and about half of the patients in each group had experienced at least one prior major depressive disorder episode.
The dropout rate in the paroxetine group was significantly higher among children aged 7–11 years, compared with the placebo group (39% vs. 13%), which suggests a lower tolerance for the drug among younger children compared with adolescents. The overall dropout rate was not significantly different between the paroxetine and placebo groups.
Possible reasons for paroxetine's lack of efficacy include a lower average daily dosage compared with a previous adolescent-only study (20.4 mg/kg vs. 28 mg/kg) and a lower adherence rate in the treatment group compared with the placebo group, the researchers said. The incidence of adverse events was similar and quite low in both groups, notably the incidence of suicidal behavior or suicidal ideation, which was 1.92% in the paroxetine group and 0.98% in the placebo group.
Paroxetine has not been approved by the Food and Drug Administration for use by either children or adolescents. The study was sponsored by GlaxoSmithKline, manufacturer of Paxil; Dr. Emslie has served as a paid consultant for the company.
Predicting Recurrent Abdominal Pain
When a child presents with recurrent abdominal pain, parents' anxiety may be a factor, reported Dr. Paul G. Ramchandani of the University of Oxford (U.K.) and his associates.
Recurrent abdominal pain (RAP)–defined as pain five or more times in the same year–was reported in nearly 12% of 8,272 children born between April 1, 1991, and December 31, 1992, as part of a prospective study. Data on predictive variables were collected when the children were 6–8 months old, and parents completed a survey when the child was almost 7 years old (J. Am. Acad. Child Adolesc. Psychiatry 2006;45:729–36).
Two maternal factors–high anxiety and somatic symptom scores–significantly predicted RAP in the children and were reported by mothers in 24% and 17% of RAP cases, respectively. Fathers' anxiety was significantly associated with RAP in 19% of cases, and the prevalence of RAP was greater when both parents were anxious (22%) than when only one parent was anxious (15%) or when neither parent was anxious (11%). No association appeared between a child's RAP and parental depression or parental stomach ulcers, and there was no significant association between RAP and early gastrointestinal illness or hospitalization in the children.
The study is the first known to present prospective data on the predisposing factors for RAP, but it was limited by the fact that all measures of pain in the children were completed by the parents, and anxious parents may be more inclined to overreport their children's symptoms, the investigators noted.
Family Stress High in ADHD
The results of a large national survey indicate that families of children with attention-deficit hyperactivity disorder show very high levels of stress, compared with families of children with other special health care needs, according to a poster presented by Dr. Ruth E. Stein at the annual meeting of the Pediatric Academic Societies.
By using data from the National Study of Children's Health, Dr. Stein and Ellen J. Silver, Ph.D., of the Albert Einstein College of Medicine, Bronx, N.Y., extracted responses from the parents of 65,613 children between the ages of 6 and 17. Of that total, 3,706 reported a diagnosis of ADHD, 10,248 children were classified as having special care needs other than ADHD, and the rest were healthy.
After adjusting for poverty level, race, family structure, age, and gender of the child, families of children with ADHD had significantly worse results on all 12 of the variables examined, compared with healthy children and compared with other children with special health care needs (CSHCN).
For example, 41% of the families with an ADHD child said they were coping very well with the day-to-day demands of parenthood, compared with 50% of the CSHCN families and 57% of the families with healthy children. That comes to an adjusted odds ratio of 0.69 for ADHD, compared with CSHCN and 0.53, compared with families with healthy children.