ABC News has learned that a Massachusetts hospital is currently recruiting pre-schoolers to test the safety and effectiveness of a powerful antipsychotic drug called Quetiapine.
The study, conducted by the Department of Pediatric Psychopharmacology at Massachusetts General Hospital, is testing subjects from four to six years of age with Bipolar Disorder. An earlier Massachusetts General study of the antipsychotic drugs Risperidone and Olanzapine recruited children as young as three years old.
These antipsychotic drugs are only approved for use by adults and are so toxic they carry a "black box warning." The drugs have been found to cause diabetes; a life-threatening nervous system problem called Neuroleptic Malignant Syndrome; low blood pressure; and have also led to higher death rates in the elderly. Despite these serious potential side-effects, a patient recruitment video obtained by ABC News contains no mention of any of these risks.
Vera Hassner Sharav of the Alliance for Human Research Protection said, "Antipsychotics were never approved for use in children whose developing brains and central nervous system may be irreversibly harmed. We believe that physicians who subject children to the toxic effects of these drugs…are practicing outside medically accepted standards."
A previous clinical trial of Olanzapine was conducted by UCLA in 1998 on five children, aged 6 to 11. The authors of the study said treatment was discontinued within the first six weeks "because of adverse effects or lack of clinically significant therapeutic response."
Sharav also said it’s questionable whether or not three or four year-olds can be accurately diagnosed for Bipolar Disorder. According to a 1999 Surgeon General report, "The signs and symptoms of mental disorders are often also the characteristics of normal development." The National Institute for Mental Health has concluded that "diagnostic uncertainty…surrounds most manifestations of psychopathology at such an early age."
Neither the hospital nor the lead investigator for the trials, Dr. Joseph Biederman, responded to our requests for a comment on the trials.