More Options for Kids’ Psychiatric Issues
words by eve jacobs /
photograph by pete byron
any families are bewildered when a child or teen is diagnosed with a mental disorder. While the why’s and wherefore’s may never be known, the good news is there are medications that work. Despite parents’ fears that a child may grow up sad, delayed and shunned in the classroom, and a discordant member of the family, the number of drugs shown to safely make a dramatic change in the mental well-being and behavior of young people has risen astronomically in the last decade. And with child and adolescent psychiatrists hot on the trail of ever better pharmaceuticals, the field of choices is mushrooming.
Theodore Petti, MD, MPH, has devoted much of his 30 plus year career to testing new therapies and discovering how to apply them successfully. He says there are many more medications available now than three decades ago, but the process of getting there has been challenging. “The criteria for a child or teen to participate in a clinical trial are very stringent,” the child psychiatrist explains, “so we screen far more than the number who actually qualify. Also, there is often ambivalence about the medications. Parents ask themselves if they can trust the system to protect their children. In addition, there is a certain amount of over-protectiveness regarding kids in clinical trials and there is a reluctance to use a placebo. Even though children often have a positive clinical response to an inert pill or capsule, people feel they are cheated if their child is placed on a placebo.”
Petti assures potential volunteers that both child and family are asked for consent to participate “no matter what age the child is,” he says, and that the child can drop out of a study at any time. “It will in no way affect the child’s care.”
Families can also agree to genetic studies, explains Petti, which allow pharmaceutical companies and clinicians to match particular genetic compositions with certain medications, increasing the likelihood of success. Although some genetic studies involve parents, “Our genetic studies focus just on the child who is getting the medicine,” he says.
Petti is currently involved in a national study of children ages 7 to 17 with anxiety, depressive, eating or obsessive-compulsive disorders to better determine the safety, tolerability, and effectiveness of newer antidepressants, including the SSRIs and SNRIs. Children and teens who would normally receive the medications for their illness are more systematically monitored and the data from more than 200 clinical practices will be integrated to help doctors better understand the balance of risk and benefit associated with these classes of medication. The study has two parts: an acute treatment phase of 12 weeks when therapy with any SSRI or SNRI that Petti would normally choose to best meet the patient's needs is administered and a long-term follow up at six and nine months after initiation of treatment.
He is also evaluating Lamictal as an add-on treatment for bipolar 1 disorder in children ages 10 to 17 who are still experiencing symptoms of their disorder with other medication. “We want to find out what effects, good or bad, Lamictal has on children and teens with bipolar disorder when taken with their other conventional bipolar medications,” he explains. Approximately 340 youngsters at about 46 research centers will participate. A comprehensive assessment is done during a screening phase and then the participants will receive the medication for up to 18 weeks. During this open label phase, evaluations will determine if the medication is working. Those who benefit from the drug will have the opportunity to move on to the randomized phase lasting up to 36 weeks where they will be assigned to either the medication or to placebo in addition to their bipolar and/or ADHD medications. The study ends with a follow-up phase of up to four weeks during which the participants are gradually withdrawn from the study medication.
Children and teens are diagnosed with a wide range of mental and behavior problems including depression, schizophrenia, autism spectrum disorders, ADHD, eating disorders, Tourette’s, substance abuse issues, and anxiety disorders.“There are many problems enrolling kids in clinical trials — it’s expensive because children can’t come on their own; people in general are reluctant to participate in clinical trials; kids in the psychiatric realm often have several disorders and may need more than one medication; in some trials, participants are needed with no co-morbid disorders that will affect the outcome; some of the studies can take years to complete,” Petti states.
“But there are such benefits to be gained, particularly for children, whose illnesses often require use of medications approved for adults, but not tested on kids.” So, Petti continues recruiting — with the hope of taking one giant step, or perhaps even five baby steps, on behalf of these children and their families.