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

NCT02078596 | Completed Phase 4

• 1 other identifier: 4592R
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Aggression

Keywords

temper outbursts; pediatric aggression; irritability

Outcome Measures

Primary Outcomes (1)

• Response

  70% reduction in overt aggression (as measured by the Modified Overt Aggression Scale) and in irritability (as measured by the six hostility items of the Hopkins Symptoms Checklist)

  6 weeks

Secondary Outcomes (2)

• Modified Overt Aggression Scale

  Baseline and at end of 6 weeks and end of 12 weeks

• Six Hostility Items of the Hopkins Symptom Checklist

  Baseline, Week 1 and weekly thereafter for up to 12 weeks

Study Arms (2)

Divalproex

EXPERIMENTAL

Divalproex at 10 mgs/lb

Drug: Divalproex

Sugar Pill

PLACEBO COMPARATOR

Equivalent 250 mg pills titrated to 10 mgs / lb over six weeks

Drug: Divalproex

Interventions

Divalproex DRUG

Patients were randomly assigned to receive divalproex or placebo first, follow by the converse treatment, for six weeks each

Also known as: Divalproex (Depakote)

Divalproex; Sugar Pill

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 1997
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: January 4, 2017

Record last verified: 2016-12

Locations

US (1)