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

NCT02078596 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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.

Primary Outcome

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)

Interventions

  • DRUG Divalproex

Trial Details

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

What the finished NCT02078596 record still lists

NCT02078596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

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

NCT02078596 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02078596's enrollment target sits among peer trials

15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01889381 · 15 participants · Phase 2

    Human Craniomaxillofacial Allotransplantation

  • NCT02530073 · 15 participants · NA

    Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

  • NCT02535936 · 15 participants · NA

    Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

  • NCT02918474 · 15 participants · NA

    Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT02078596, the US trial registry maintained by the National Library of Medicine. NCT02078596 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.