Columbia University Medical Center

Research Units Established To Evaluate Medications In Children With Mood Disorders

Study Launched to Test Selective Serotonin Reuptake Inhibitor in Children Suffering from Anxiety Disorders

NEW YORK — Aug. 26, 1997 — Nearly 12 million children and adolescents are diagnosed with emotional disorders, including anxiety and depression, in the United States each year. Yet because the medications used to treat these disorders are tested mainly on adults, little is known about their safety and efficacy in children and adolescents. Now, a new National Institutes of Health research center at Columbia University’s College of Physicians & Surgeons aims to correct that deficit.

The center, called the Research Unit in Pediatric Psychopharmacology (RUPP), is one of only three units in the country; the other units are located at Johns Hopkins University and the University of Pittsburgh. Studies at the center aim to shed light on the use of medicines for mood and anxiety disorders in children. Other research trials will be identified and set up at universities and hospitals throughout the United States. The RUPPs will be networked with the existing centers. At Columbia-Presbyterian Medical Center, one study is about to begin. The eight-week study, under the direction of Laurence Greenhill, M.D., principal investigator, research psychiatrist at the New York State Psychiatric Institute, and associate professor of clinical psychiatry at Columbia University, and Daniel Pine, M.D., co-principal investigator and assistant professor of clinical psychiatry, will monitor the effects of fluvoxamine (LUVOX® Tablets) in children and adolescents. The same study will be held at the Johns Hopkins Medical Institutions, under the direction of Mark Riddle, M.D., director of the division of child and adolescent psychiatry.

“I am glad to see progress in research on these disorders in children,” said Steven Hyman, M.D., director of the National Institute of Mental Health. “It is long overdue.”

Trial Design

This new study will involve 200 children, ages 7 to 17 years, who have moderate to severe generalized anxiety disorder, social phobia, or separation anxiety disorder. The children will receive one dose of fluvoxamine twice a day, ranging from 25mg daily at baseline to between 250mg and 300mg daily (given to them by their parents). At weekly follow-up visits, researchers will check for the drug’s effectiveness and any side effects. The children will be monitored for long-term effects for a period of six months following treatment. According to Dr. Greenhill, this study will help researchers gain important insights on the use of medication for childhood anxiety. “Anxiety disorders are more widespread in children than pediatricians once thought,” said Dr. Greenhill. “It is our hope that selective serotonin reuptake inhibitors such as fluvoxamine may prove beneficial in the treatment of these disorders in children and adolescents.”

Use of Fluvoxamine in Pediatric and Adolescent Populations Fluvoxamine has been demonstrated to be effective for the treatment of obsessive-compulsive disorder (OCD) not only in adults but also in children and adolescents. A 10-week randomized, double-blind, placebo-controlled, multi-center study that tested the relative safety and efficacy of fluvoxamine in 120 children and adolescents with OCD showed that fluvoxamine is more effective than placebo for the treatment of OCD.

Other Research Unit Studies

In addition to studying the effectiveness of fluvoxamine for anxiety disorders, scientists at the Columbia Research Unit in Pediatric Psychopharmacology will examine the relationship between the children’s genes and their response to fluvoxamine.

Researchers will also initiate studies measuring the safety of the commonly prescribed combination of Ritalin-Clondine in children with attention deficit hyperactivity disorder (ADHD) and testing the efficacy of buspirone transdermal patches for the treatment of ADHD. For depressed children, Columbia University’s RUPP will examine the use of fluoxetine for the treatment of dysthymia – a mild but chronic form of depression – and will study whether antidepressant medication is useful for treating major depression in children. To further support ongoing research efforts, the department of child and adolescent psychiatry at CPMC and NYSPI has established the Joy and William Ruane Center for the Early Identification and Treatment of Mood Disorders.

About CPMC

Columbia-Presbyterian Medical Center is the world’s oldest academic medical center. It aligns the Presbyterian Hospital with Columbia University Health Sciences Division and includes the New York State Psychiatric Institute. The Health Sciences Division consists of the College of Physicians & Surgeons, and the Schools of Dental and Oral Surgery, Public Health, and Nursing. All members of the CPMC medical staff have an academic appointment at one of the schools in the Health Sciences Division.

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