Parents with children taking antidepressant medications may want to reconsider the therapy as most research suggests it may do more harm than good.
A team of researchers conducted a meta-analysis of available data and concluded that out of 14 available antidepressants, few drugs have been found to help children with their depression.
The only effective antidepressant for children and adolescents with major depression, the researchers said, is fluoxetine, sold under the brand names Prozac and Sarafem.
This selective serotonin reuptake inhibitor (SSRI) is the only one with reliable research to back its effectiveness when compared with a placebo, the researchers said.
On the other end of the spectrum is venlafaxine (Effexor), which is linked with an increased risk of suicidal thoughts and attempts at suicide when compared with placebo and five other antidepressants.
“When considering the risk–benefit profile of antidepressants in the acute treatment of major depressive disorder, these drugs do not seem to offer a clear advantage for children and adolescents,” the study, published in The Lancet, concludes.
The study’s lead author, Dr. Andrea Cipriani at the University of Oxford, says while clinical guidelines recommend psychotherapy as the first-line intervention, it is important to avoid a one-size-fits-all approach.
“Children and adolescents taking antidepressant drugs should be closely monitored regardless of the treatment chosen, particularly at the beginning of treatment,” he told Healthline. “If a child or adolescent is taking an antidepressant that works for his/her depression, it should not be changed to fluoxetine.”
Dr. David Fassler, a child and adolescent psychiatrist and member of the American Academy of Child and Adolescent Psychiatry (AACAP), who wasn’t involved in the study, says the review is generally consistent with several previous meta-analyses.
Overall, he said, while medication can be helpful for some children and adolescents with depression, medication alone is rarely the best intervention. Medication, he said, should only be used as part of a plan that’s been individualized to the needs of the child and family.
“We also know that many of these young people can be treated successfully without medication,” Fassler told Healthline. “The real challenge is to make sure that children and adolescents with depression and other psychiatric disorders have access to the most appropriate and effective treatment possible.”
If you do have reservations about the antidepressant your child is taking, don’t immediately discontinue use, as this may create unwanted side effects. Talk to your child’s doctor before making any changes to their prescription medications.
The controversy around antidepressants, children
Overall, researchers discovered that the extent of serious harmful side effects, such as suicidal thoughts or attempts, is unclear because of the way studies are designed, or the way they selectively report their findings.
The latest study’s co-author, Peng Xie from The First Affiliated Hospital of Chongqing Medical University in Chongqing, China, said the balance of risks and benefits of antidepressants for the treatment of major depression does not seem to offer a clear advantage in children and teenagers, with the exception of fluoxetine.
“We recommend that children and adolescents taking antidepressants should be monitored closely, regardless of the antidepressant chosen, particularly at the beginning of treatment," Xie said in a press release.
In 2004, the U.S. Food and Drug Administration (FDA) issued a public warning about the potential risks of suicidal thoughts and behaviors for children taking SSRIs. In 2006, it extended that warning to include anyone under the age of 25.
Use is on the rise
Despite these concerns, use of antidepressants in children in the United States is increasing. From 2005 to 2012, antidepressant use in children under the age of 19 increased from 1.3 percent to 1.6 percent, the greatest increase coming among 15 to 19 year olds.
With 74 million people in the United States under the age of 18, that’s just under 1.2 million children taking antidepressants.
The most widely prescribed antidepressant?
The SSRI sertraline (Zoloft). In the United Kingdom, however, fluoxetine is the most commonly prescribed antidepressant for children.
The Lancet meta-analysis ranked antidepressants by efficacy, tolerability, acceptability, and associated serious harms. It also assessed the quality of the studies, including their risk of bias.
In the 34 drug trials, with 5,260 participants ages 9 to 18, fluoxetine was the only drug where the benefits outweighed the risks in terms of efficacy and tolerability.
The other drugs didn’t fare as well compared with other drugs and placebos.
Nortriptyline (Pamelor) was less effective than placebo and seven other antidepressants.
Imipramine (Tofranil), venlafaxine (Effexor), and duloxetine (Cymbalta), were the worst in terms of tolerability, meaning more people discontinued their use.
Venlafaxine (Effexor) was linked with an increased risk of engaging in suicidal thoughts or attempts.
Questionable data clouds the issue
Since 65 percent of the studies looking into the use of these drugs in children have been funded by the drug manufacturers themselves, researchers were careful to assess the risk of bias related to the studies’ findings.
A third of the drug trials were marked as “high risk of bias,” and nearly 60 percent of the studies were considered moderate bias risks.
Drug companies are not required to turn over all their research for a drug. This creates a problem of reliable data.
Without that data, researchers warn, it was not possible to comprehensively assess the risk of suicidal behavior for all drugs.
Cipriani says without access to individual patient data, they cannot be completely confident about the accuracy of the information contained in published and unpublished trials.
“It has been widely argued that there needs to be a transformation of existing scientific culture to one where responsible data sharing should be the norm,” he said. "Hundreds of thousands of people worldwide have agreed to participate in trials aiming to find better treatments for their disorders and, ultimately, help the progress of medical science.”
While patient privacy remains important, delaying data sharing has negative consequences for medical research and patient outcomes, Cipriani said.
“Access to raw clinical trial data provides the unique opportunity not only for validation and replication of results, but also the in-depth study of specific factors that may affect treatment outcome at the individual patient level,” he said.