AACAP Psychopharmacology Committee Statement on Ketamine

May 8, 2018

AACAP’s Psychopharmacology Committee monitors closely the availability of antidepressants for children and adolescents. At this time, there are only two FDA-approved medications for adolescents with depression and one for children. There have been a lot of questions by clinicians regarding referring patients for ketamine infusions (which are not approved to treat depression in any age group adult or child) or prescribing esketamine.

However, there are a lack of controlled studies in children and adolescents for ketamine or esketamine so clinicians should use extreme caution when prescribing either formulation. Additionally, as in any prescribing of off-label medications, the physician has more responsibility to look at available safety data, or the lack thereof. Therefore, esketamine is not proven to be safe or indicated in children and adolescents, and AACAP’s Psychopharmacology Committee does not currently recommend its use in this population.

For your reference, highlights of FDA’s recent decision regarding esketamine follows. View full prescribing information. 

FDA has approved intranasal esketamine for the treatment of treatment-resistant depression (TRD) in adults (18 and older). TRD is defined as failure of at least two previous antidepressants given at adequate doses and for adequate duration. It is approved for use in conjunction with an oral antidepressant (in clinical trials, a new oral antidepressant was initiated at the same time as double-blind intranasal esketamine or intranasal placebo).

Dissociation and sedation are common adverse reactions. Given the risks associated with dissociation and sedation, as well as the risks of abuse and misuse, esketamine is only available through a restricted distribution system under a risk evaluation and mitigation strategy (REMS). Esketamine can only be dispensed from a certified pharmacy, administered in a certified healthcare facility, and provided to patients who are enrolled in a patient registry. Patients must be monitored for two hours after administration until symptoms of sedation and dissociation resolve.

Dose-dependent increases in blood pressure were also observed in clinical trials in adults. Blood pressure should be assessed prior to administering esketamine, about 40 minutes after administration (to coincide with Tmax), and before discharging the patient from clinic.

The dosing schedule for esketamine is as follows: twice/week for first 4 weeks, once per week for the next 4 weeks, then once per week or every other week thereafter. Patients should be re-evaluated after the first 4 weeks to determine the need for continued treatment.

Esketamine is not indicated for pediatric patients. A study of esketamine for rapid reduction of symptoms of depression, including suicidal ideation, in adolescents assessed to be at imminent risk for suicide is ongoing. Therefore, esketamine should not be used in this population outside of current research protocols.

View the full FDA press release.