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

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ClinicalTrials.gov Identifier: NCT02078596
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.


Condition or disease Intervention/treatment Phase
Irritable Aggression Drug: Divalproex Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings
Study Start Date : March 1997
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Divalproex
Divalproex at 10 mgs/lb
Drug: Divalproex
Patients were randomly assigned to receive divalproex or placebo first, follow by the converse treatment, for six weeks each
Other Name: Divalproex (Depakote)

Placebo Comparator: Sugar Pill
Equivalent 250 mg pills titrated to 10 mgs / lb over six weeks
Drug: Divalproex
Patients were randomly assigned to receive divalproex or placebo first, follow by the converse treatment, for six weeks each
Other Name: Divalproex (Depakote)




Primary Outcome Measures :
  1. Response [ Time Frame: 6 weeks ]
    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)


Secondary Outcome Measures :
  1. Modified Overt Aggression Scale [ Time Frame: Baseline and at end of 6 weeks and end of 12 weeks ]
    Measures the severity and frequency of aggressive outbursts producing a single score theat comes the frequency and severity

  2. Six Hostility Items of the Hopkins Symptom Checklist [ Time Frame: Baseline, Week 1 and weekly thereafter for up to 12 weeks ]
    This is a scale that measures irritability items on a 1-5 scale, yielding a total score of up to 30 for the six items



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078596


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02078596     History of Changes
Other Study ID Numbers: 4592R
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016

Keywords provided by New York State Psychiatric Institute:
temper outbursts
pediatric aggression
irritability

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs