Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00217932
Other study ID # NIDA-00451-1
Secondary ID K02-00451-1DPMC
Status Completed
Phase Phase 2
First received September 16, 2005
Last updated January 11, 2017
Start date September 2000
Est. completion date August 2005

Study information

Verified date April 2006
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) versus placebo in treating children with temper outbursts and severe mood disorders.


Description:

Depakote has been used to treat seizures in children for more than 20 years. The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) in treating children with temper outbursts and severe mood disorders.

This study will last 12 weeks. Participants will be randomly assigned to receive either 250 mg Depakote or placebo. The dose of medication will increase at the end of Week 1 to 500 mg of either depakote or placebo; participants will remain on this dose through Week 5. At Week 6, participants will cross-over and receive the other treatment (either depakote or placebo), which they will take through Week 12. Study visits will occur weekly and will include a physical exam, blood and urine tests, and self-reports of adverse events. In addition, caregivers will complete reports about mood swings throughout the study.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria:

- Meets criteria for Explosive Mood Disorder (EMD)

- Explosive temper as evidenced by four or more outbursts of rage, property destruction, or fighting per month

- Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant

- History of an EMD for one year without treatment

- EMD symptoms resulting in impairment in two or more of the following areas: school, the law, family, substance use, peers, or work

- EMD symptoms do not occur only during substance toxicity or withdrawal

- EMD symptoms are 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 neurologic disturbance

- Pregnant

- Moderate to severe mental retardation

- Physical exam or laboratory results with significant abnormalities

- Positive Hepatitis screen test

- Liver dysfunction

- Active suicidal or homicidal ideation

- History of suicide attempts

- History of barbiturate use

- Unequivocal manic or hypomanic episode

- Meets criteria for attention deficit hyperactivity disorder (ADHD) and has not failed a trial of psychostimulants for ADHD

- Meets criteria for major depression in prepuberty

- If female, unwilling to use an effective method of contraception for the duration of the study

- Mitochondrial disease or family history of mitochondrial disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Divalproex Sodium (Depakote)


Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Recruiting NCT05345392 - Brain, Emotions, and Mind-Wandering N/A
Completed NCT05078450 - Mood Lifters Online for Graduate Students and Young Professionals N/A
Not yet recruiting NCT04551027 - Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness N/A
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Active, not recruiting NCT02542475 - Low Field Magnetic Stimulation: Open Label Study. Phase 1/Phase 2
Completed NCT00916552 - Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder Phase 2
Completed NCT00202514 - Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms Phase 2/Phase 3
Completed NCT00006517 - Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD) N/A
Terminated NCT03898843 - Assisted Animal Therapy: ReAnimal N/A
Active, not recruiting NCT04358900 - Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)
Recruiting NCT06360562 - Reconnecting to Ourselves and Others in Virtual Meetings (ROOM) N/A
Completed NCT05745103 - Optimizing Behavioral Healthcare Delivery Through Technology N/A
Suspended NCT03715400 - Mobile Virtual Positive Experiences for Anhedonia N/A
Enrolling by invitation NCT03736538 - Nitrous Oxide- Suicidal Ideation Phase 1
Completed NCT04601545 - The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method N/A
Completed NCT02566980 - Biological Triggers of Depression in Pregnancy
Completed NCT03743844 - Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity N/A
Completed NCT05211063 - Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders N/A
Completed NCT02766101 - Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges N/A