Zoloft Found Safe, Effective in Children 

Study Findings Support Current Use

Researchers have found that an antidepressant used in children and adolescents for major depressive disorder (MDD) appears to be safe and effective, according to a new study reported in the Journal of the American Medical Association (JAMA).

The antidepressant Zoloft®, known generically as sertraline, is one of a class of drugs called selective serotonin reuptake inhibitors (SSRIs).

According to the report, up to 3 percent of children and 8 percent of adolescents have MDD. The lifetime likelihood of having depression for youths aged 15 to 18 years old has been estimated at 14 percent to 15 percent - rates comparable with those of adults.

Although the medications are commonly considered to be the best available pharmaceutical option for depressed children and teens, there have been very few studies done in this age group.

"There is a gap between our use of medications and the study of the medications," says Dr. Karen Dineen Wagner, lead author of the study. Dr. Wagner is director of child and adolescent psychiatry at the University of Texas Medical Branch in Galveston.

The antidepressant medications are usually studied first in adults and, once approved, are prescribed "off label" for children and teens.

"The problem is that I think less than 20 percent of medications are actually indicated [approved] for children, but a large percentage of them are used for children," says Dr. Eugenio Rothe, at the University of Miami School of Medicine and director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital.

"You can justify pediatric use if the medication has been proven to be effective in adults and you dose it according to the milligram per weight that's available for children," Dr. Rothe says.

The reason for this dearth of research is that it is very difficult to get approval for studies of antidepressants involving children. Institutional review boards of major institutions are often reluctant to approve them, and parents are often hesitant to involve their children, Dr. Rothe explains.

Depression Recognized More Frequently

However, the use of prescription antidepressants in children has skyrocketed during the last 10 to 15 years.

"The numbers vary a little, but the order of magnitude of increases in that period of time is something of the order of six to 10 times," says Dr. Christopher Varley, author of an accompanying editorial in JAMA and professor of child and adolescent psychiatry at the University of Washington School of Medicine in Seattle.

The current study represents something of a breakthrough, especially given that it is the largest psychopharmacological study of MDD in children and teens that showed a positive result.

The researchers looked at 376 children, ages 6 to 17, with MDD. In all, 53 hospitals, general practice, and academic centers in five countries were involved. The children were randomly assigned to receive either Zoloft® or a placebo (inactive substance) for 10 weeks. Changes in their depression were measured by the Children's Depression Rating Scale-Revised.

At the end of the 10-week study, 69 percent of the children on Zoloft® showed improvement, compared to 59 percent in the placebo group.

"By about three weeks, children in the medication group started to have more significant improvement than those in the placebo group, and these children had been ill for long periods of time," Dr. Wagner says. "The average length of illness was about two years."

Experts Say New Findings May Help Children

Says Dr. Varley: "It shows that kids got better compared to a placebo, but it wasn't like night and day. It didn't knock your socks off, but it was there. It's absolutely a good thing."

Dr. Rothe says, "Every time one of these studies comes across with conclusive research findings, it's one more hurdle that we've crossed because it's very difficult to help children with the present regulations. We've been using Zoloft® for a long time, and this just validates the situation."

The new study was funded by Pfizer, which makes Zoloft®.

Always consult your child's physician for more information.

Online Resources

(Our Organization is not responsible for the content of Internet sites.)

American Academy of Child and Adolescent Psychiatry

American Academy of Pediatrics

Centers for Disease Control and Prevention (CDC)

National Institute of Child Health and Human Development (NICHD)

National Institute of Mental Health (NIMH)

National Institutes of Health (NIH)

National Library of Medicine, at NIH

October 2003

Zoloft Found Safe, Effective in Children

Depression Recognized More Frequently

Experts Say New Findings May Help Children

Symptoms of Major Depression

How Is Major Depression Diagnosed?

Online Resources

Symptoms of Major Depression

The following are the most common symptoms of major depression:

• persistent feelings of sadness

• feeling hopeless or helpless

• having low self-esteem

• feeling inadequate

• excessive guilt

• feelings of wanting to die

• loss of interest in usual activities or activities once enjoyed

• difficulty with relationships
  sleep disturbances such as insomnia or hypersomnia

• changes in appetite or weight

• decreased energy

• difficulty concentrating

• a decrease in the ability to make decisions

• suicidal thoughts or attempts

• frequent physical complaints such as headache, stomach ache, or fatigue

• running away or threats of running away from home

• hypersensitivity to failure or rejection

• irritability, hostility, or aggression
  

For a diagnosis of major depression to be made, a child often needs to exhibit a "cluster" (several) of the above symptoms during the same two-week period.

Always consult your child's physician for a diagnosis.

How Is Major Depression Diagnosed?

Because depression has shown to often co-exist with other psychiatric disorders, such as substance abuse or anxiety disorders, seeking early diagnosis and treatment is crucial to the recovery of your child.

A child psychiatrist or other mental health professional usually diagnoses major depression following a comprehensive psychiatric evaluation. An evaluation of the child's family, when possible, in addition to information provided by teachers and care providers, may also be helpful in making a diagnosis.

Mood disorders, including major depression, can often be effectively treated. Treatment should always be based on a comprehensive evaluation of the child and family.

Parents play a vital supportive role in any treatment process. Without appropriate treatment, symptoms of depression can persist for weeks, months, or years.

In addition to causing interpersonal and psychosocial problems, depression in children and adolescents is also associated with an increased risk for suicide.

Further, this risk rises, particularly among adolescent boys, when the depression is accompanied by other mental health disorders such as conduct disorder, substance abuse.

Always consult your child's physician for more information.