Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02078596 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 4
Development phase
15
Enrollment target

NCT02078596 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 15 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02078596, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 4
Development phase
15 participants
Enrollment target

Study 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.

Interventions

  • DRUG Divalproex

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 1997-03
Est. Completion 2004-03
Phase Phase 4

What the Registry Record Tells You About NCT02078596

The ClinicalTrials.gov registry entry for NCT02078596 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Divalproex is the first listed.

NCT02078596 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02078596 about?

NCT02078596 is a clinical study titled "Depakote (Divalproex Sodium) for Children With Temper Dysregulation and Severe Mood Swings". 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 usua...

What is the current status of trial NCT02078596?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 1997-03. Estimated completion is 2004-03.

What interventions are being tested in trial NCT02078596?

The interventions under investigation include: Divalproex (DRUG).

Who is sponsoring clinical trial NCT02078596?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.