Depakote (Divalproex Sodium) for Children With Temper Dysregulation and Severe Mood Swings

Completed · Phase 4 · Has a placebo group

Conditions studied: Irritable Aggression

In brief

Though the Disruptive Disorders of Childhood and Adolescence are a major source of morbidity and fill a large proportion of special education slots, specific pharmacologic treatment is available only for those children with Attention Deficit/Hyperactivity Disorder. Other disruptive children are usually said to "have" Oppositional Defiant or Conduct Disorder. These diagnoses are useful descriptively but they do not have specific treatment implications In the course of treating adolescents with explosive tempers and severe mood swings with Depakote (divalproex sodium), the investigators learned that younger children manifest symptoms that seemed identical to those constituting the adolescent disorder. They were in special education programs and not responding to psychostimulants. The investigators systematically collected data on these children using the same screening criteria as in our studies of adolescents. Since Depakote has been used to treat seizures in children for more than twenty years, a great deal was known about its safety profile in the pediatric population. The investigators treated 7 children, age 7-12, whose recurrent temper outbursts and chronic mood lability did not respond to individual/family therapy. After parents signed informed consent and children gave assent, these subjects would receive open label Depakote in doses sufficient to reach a blood level between 50-100 micrograms/ml for six weeks. The family received supportive therapy.

Key facts

Study ID

NCT02078596

Run by

New York State Psychiatric Institute

People needed

15

Starts

1997-03-01

Expected to finish

2004-03-01

Last updated by the study team

2017-01-04

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 7-11
• Meets Screening Criteria (i.e. "Explosive Mood Disorder") A) An explosive temper as evidenced by four or more outbursts of rage, property destruction or fighting per month on minimal provocation B) Mood lability as evidenced by multiple, daily,distinct, shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant C) Duration of at least one year when not treated D)Symptoms result in impairment in two or more areas including: school, the law, family, substance use, peers, work E)Symptoms do not occur only during substance toxicity or withdrawal. F)Symptoms not confined to a single setting or context
• Parent and child willing to consent to study
• Inadequate response to an Adequate trial (8 weeks) of Psychotherapy and/or family therapy

You may not qualify if…

• Meets criteria for Pervasive Developmental Disorder or Childhood Schizophrenia
• Seizure or other neurological disturbance
• Pregnancy
• Moderate to severe mental deficiency
• Physical exam or laboratory results with significant abnormalities
• Active suicidal or homicidal ideation or history of suicide attempts
• Use of Barbiturates
• Unequivocal manic or hypomanic episode
• Meets criteria for Attention Deficit Hyperactivity Disorder and has not failed a trial of psychostimulants
• Meets criteria for Major Depression in prepuberty
• Sexually active females who are unwilling to use effective methods of contraception.
• Mitochondrial disease or family history of mitochondrial disease

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.