SAN DIEGO – Vigilantly monitor depressed children and adolescents during the first month of selective serotonin reuptake inhibitor therapy–especially during the first 10 days, David Sack, M.D., said at a psychopharmacology congress sponsored by the Neuroscience Education Institute.
See the patient face-to-face at least weekly during that first month, and make sure that someone is monitoring the patient between visits. “It isn't enough to begin monitoring them when they show up at the office” for follow-up, said Dr. Sack of White Plains, N.Y.
Selective serotonin reuptake inhibitors (SSRIs) lack consistent data showing effectiveness in treating depression in children and adolescents, and metaanalyses of pediatric SSRI use show a slight but consistently significant increased risk of suicidal behavior with the drugs. The Food and Drug Administration's recent addition of a black box warning to labeling for SSRIs notes the risks of antidepressants in children.
An informal poll of several hundred physicians at the meeting showed that about half routinely schedule 1-week follow-ups after starting SSRIs in depressed children and adolescents. The first and second weeks “are very high-risk periods. If we're going to treat children with SSRIs, then we're going to have to modify the way we follow them up,” he said.
Studies of depressed adults treated with SSRIs suggest that the risk of suicidal behavior is four times higher in the first 7 days, compared with other times in the first 90 days. In the first month of treatment, the risk of suicidal behavior is three times higher than in the following 60 days.
Vigilant monitoring during these high-risk periods is a challenge for most medical practices. “As hard as it is for a psychiatrist to maintain contact in the first week, it's even more difficult for many pediatric practices,” Dr. Sack noted.
Front-office nurses or other personnel may not have the knowledge to assess over the phone whether a patient has had a change in behavior. “We have a lot of work to do in terms of our training and understanding to make this a reality in practice,” he said.
Patients with a history of prior suicide attempt or previous antidepressant therapy failure are at increased risk for suicidal behavior on SSRIs.
Before starting SSRI therapy in a child or adolescent, rule out bipolar disorder as much as possible. Give verbal and written information to families about the lack of consistent benefit with SSRIs in depressed pediatric patients and the apparent increase in risk of suicidal ideation. Respect a family's decision if they refuse SSRI therapy for the patient, Dr. Sack instructed.
Families should be told to contact the physician's office if they see changes suggesting suicidal thinking or behavior. “They need to know that changes in hopelessness or suicidal ideation are an emergency,” he said.
The need to change dosages or drugs should be a sentinel for increased risk, he added. Pay special attention about 3–4 weeks after starting therapy, which is when most switches occur.
Use the weekly visits and monitoring in between to look for and respond to signs of suicidality, and to avoid a lawsuit in the event that something goes wrong, write down everything done to monitor the patient, Dr. Sack said.
None of the pediatric trials individually showed an increased risk of suicidality. Only when the data were pooled did that risk emerge. Pooled estimates suggest up to a doubling of risk for suicidal ideation in children on SSRIs, compared with placebo.
Only one out of five placebo-controlled studies of SSRIs in children and adolescents showed efficacy in treating depression, but that may be attributable to the studies' designs, Dr. Sack said. A separate 2004 study suggested that every 1% increase in adolescent use of SSRIs for major depression decreases the suicide rate by 0.23 per 100,000 adolescents.