A multi-site study to evaluate treatments for anxiety disorders in children and adolescents, funded by the National Institute of Mental Health (NIMH), found that a medication was more than twice as effective as the placebo, or sugar pill. The research trial, which cost $1.7 million, involved 128 children and adolescents ages 6 to 17 over a period of eight weeks. Symptoms improved in 76 percent of those randomly assigned to take the medication, compared to only 29 percent of those in the placebo group. The study, "Fluvoxamine For The Treatment Of Anxiety Disorders In Children And Adolescents," is being published this week in the New England Journal of Medicine.

Questions and Answers

Q1: What was the goal of this study?

A1: To test whether a medication was safe and efficacious in decreasing anxiety in children and adolescents (age 6-17 years) with anxiety disorders, which cause much suffering in children.

Q2: What is the most important finding of the study?

A2: The medication was more effective than a pill placebo for children and adolescents suffering from anxiety disorders over a period of treatment of 2 months. At the end of the 2 months of the study, 76% of the 63 children who were randomly assigned to the medication were improved as compared to only 29% of the 65 children assigned to placebo. No severe side effects occurred on the medication.

Q3: What medication was used in the study?

A3: The medication that was used in the study was fluvoxamine, which belongs to a class of medications called selective serotonin re-uptake inhibitors or SSRIs that are used to treat mood and anxiety disorders in adults

Q4: Why is it important to study ways to treat anxiety disorders in children?

A4: Anxiety disorders are the most common mental health disorders in children and adolescents. Still, they are often not recognized, and most children and adolescents who have these disorders are not treated. These disorders cause significant suffering and functional impairment in the affected children. While not all of them will continue to suffer from these disorders into adulthood, some will, and early treatment may help prevent future mental health problems, including depression and suicide.

Q5: Which anxiety disorders did these children have?

A5: In order to be randomized to medication or placebo, the children needed to have at least one of these disorders: generalized anxiety disorder, separation anxiety disorder, or social phobia.

Q6: What are the typical signs of anxiety disorders in children?

A6: Common signs of anxiety disorders are excessive worry about ordinary activities, such as going to school or summer camp, taking a test, participating in sports, fear upon separation from parents, talking in front of others, eating in public, or using the phone. At times, there are somatic symptoms such as palpitations, sweating, trembling, stomachache, or headache. There may be avoidance of certain situations that are perceived by the child to be sources of anxiety. This avoidance can cause social withdrawal. When these symptoms interfere with the functioning of the child in usual activities, we can talk of an 'anxiety disorder'.

Q7: How are these disorders diagnosed?

A7: These disorders are properly recognized through a careful evaluation that includes direct examination of the child, an interview with the parents and collection of past history. For this study, the children and adolescents had to go through an additional period of extended evaluation, which lasted three weeks and during which supportive psychotherapy was initiated. Only children who had not adequately improved at the end of that period were entered into the medication study. This was done to avoid exposing to medications children who might have improved with simple support and encouragement.

Q8: Why is the study important?

A8: This is the first placebo controlled multi-site study of an SSRI in children and adolescents with anxiety disorders.

Q9: What were the most common side effects?

A9: Both the children on fluvoxamine and those on placebo had complaints of possible side effects. However, only stomachache was more frequent among the children on fluvoxamine (49%) than those on placebo (28%). The medication was also associated with greater increases in children's levels of activity than was the placebo. The side effects, however, were usually mild, and only five of the 63 children in the medication group discontinued treatment as a result of these adverse events, as compared with one of the 65 children in the placebo group.

Q10: Do the results imply that children with anxiety should be treated with medications?

A10: No, children suffering from anxiety that impairs their functioning should be carefully evaluated by a health care professional who is familiar with childhood anxiety disorders. Several treatment options exist. These include both psychotherapy and medication. A specific form of psychotherapy, cognitive behavioral therapy, has been shown to be effective in children with these disorders.

Q11: Do children outgrow these disorders? What percent do? Do they outgrow them whether you treat them or not?

A11: About 50 percent of children and adolescents who are diagnosed with anxiety disorders outgrow them, but these are children who are diagnosed and treated while they are young. We have no data on untreated children and adolescents with anxiety disorders.

Q12: How many children and adolescents participated in the study?

A12: A total of 128 subjects were randomized across the 5 sites. 63 were assigned to the medication and 65 to placebo. The age range was from 6 to 17 years. Most of the participants (75%) were under age 13. Half were boys. About 65% were white and the rest from minority ethnic groups.

Q13: Who funded the study? How much did it cost?

A13: The study was conducted under contracts from the National Institute of Mental Health to the Research Units of Pediatric Psychopharmacology (RUPP) Network. The study cost about $1.7 million over a period of about 3 years.

Q14: What is the RUPP network?

A14: The RUPP network is a network of research units, at universities around the country, whose infrastructure is supported by NIMH. These units are devoted to conducting studies to test the efficacy and safety of medications commonly used by practitioners to treat children and adolescents but not adequately tested ('off-label' use).

Q15: Where was the study conducted?

A15: The study was conducted at 5 sites of the Research Units of Pediatric Psychopharmacology Network: Johns Hopkins University in Baltimore, New York State Psychiatric Institute and New York University in New York City, Duke University Medical Center in Durham, NC, and University of California in Los Angeles. The data were collected at the Nathan Kline Institute (NY). The study was funded and coordinated by the National Institute of Mental Health (NIMH).