Mood DisordersPhase 2NCT00217932
Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings
A Phase 2 study testing Divalproex Sodium (Depakote) in people with Mood Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Mood Disorders
- What is being tested?
- Divalproex Sodium (Depakote)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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- Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings
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.
Read the detailed 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.
- Conditions
- Mood Disorders
- Being tested
- Divalproex Sodium (Depakote)
- Keywords
- Behavioral Disorders
- Medical subject headings
- Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium (Depakote)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2000
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen Donovan, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217932
- Sponsor's protocol ID
- NIDA-00451-1
- Other IDs
- K02-00451-1, DPMC
- Status last verified
- Apr 2006
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings
- ClinicalTrials.gov ID
- NCT00217932
- Acronym / sponsor ID
- NIDA-00451-1
- Conditions
- Mood Disorders
- Keywords
- Behavioral Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- Aug 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Divalproex Sodium (Depakote) | Drug | – |
Primary outcome
Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Donovan, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Divalproex Sodium (Depakote) in people with Mood Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.