Bipolar DisorderPhase 4NCT00199966
Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder
A Phase 4 study testing Divalproex sodium extended release in people with Bipolar Disorder, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this research is to compare how safely and how well this medicine works in treating children and teenagers between the ages of 6 and 17 years with a diagnosis of Bipolar Disorder. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Divalproex sodium extended release
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Nov 2005
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Bipolar I or II confirmed by K-SADS and clinical interview.
- Ages 6 to 17 years 11 months.
- YMRS score of <10, this is consistent with minimal symptoms of mania. Or a desire to change medications due to a simplified dosing schedule or to reduce unwanted side effects of divalproex sodium.
- Ability and willingness of subject and parent(s)/guardian(s) to provide informed written assent/consent.
Who cannot join
- Diagnosis of: Pervasive Developmental Disorders, Schizophrenia spectrum disorders, Obsessive Compulsive Disorder.
- Concurrent medical conditions requiring medication or that are unstable.
- Current suicidal thoughts.
- Recent suicidal behavior.
- Pregnancy or sexually active female not using a reliable form of contraception.
- Previous inadequate response to DVP ER.
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- Known hypersensitivity to DVP or DVP ER.
- Recent inpatient hospitalization for suicidality or homicidality, (last 6 months).
- Subjects who are clinically stable and not suffering significant side effects on their current medical regimen.
- Use of antidepressants within the last 2 weeks, 4 weeks for fluoxetine.
- Recent (last 3 months) substance abuse or dependence. Urine drug screen will be obtained if a question arises.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
About this study
Official title: A Pilot Study Of Safety And Effectiveness For Depakote ER In Pediatric Bipolar Disorder
The purpose of this research is to compare how safely and how well this medicine works in treating children and teenagers between the ages of 6 and 17 years with a diagnosis of Bipolar Disorder.
Read the detailed description
There is no accepted, well-studied treatment for Pediatric Bipolar Disorder and treatment has often followed from adult studies. The primary objectives for this study are to determine if subjects can safely and easily be switched from divalproex sodium to Depakote ER and to determine if Depakote ER is both safe and effective for pediatric patients with Bipolar I or II. Secondary objectives include determining the serum levels of valproic acid 20 hours after administration of Depakote ER at a steady rate and determining if co-administration of stimulants will effect the serum levels of valproic acid. Thirty subjects, ages 6-17 years, with a diagnosis of Bipolar I or II who are currently asymptomatic, according to a score of less than 10 on the Young Mania Rating Scale, or who desire to change to once daily dosing, or desire to change because of the likelihood of decreased side-effects, will be recruited from our clinic and the community. If subjects have completed baseline evaluations (including diagnostic confirmation), labs, and rating scales and are still eligible to participate, subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex sodium extended release (DVP ER).
The potential benefits of the research are that new information will be added to the field of child and adolescent psychiatry and the possibility that the medication change may result in improved symptoms of mania or side effects of medications related to peak and trough levels. The potential benefits of this study outweigh the possible risks.
- Conditions
- Bipolar Disorder
- Being tested
- Divalproex sodium extended release
- Keywords
- Bipolar Disorder; Pediatric Bipolar Disorder; Depakote ER
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex sodium extended releaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Mania Rating Scale (YMRS), rate at baseline, Week 2,4,6,&8
Secondary outcomes (5)
Kiddie version of the Schedule for Affective Disorders and Schizophrenia (KSADS), assessed at baseline only.
Child Depression Rating Scale (CDRS), rate at baseline through Week 8.
Clinical Global Impression: Improvement and Severity (CGI), for mania, depression and ADHD. Rate from baseline through Week 8.
Conner's Parent and Teacher Rating Scales (CRS). Rate from baseline through Week 8.
Side Effect For Children & Adolescents (SEFCA). Rate from baseline through Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Investigators
- Russell E Scheffer, MD, Principal investigator, Medical College of Wisconsin; Children's Hospital of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199966
- Sponsor's protocol ID
- CHW 03/163, HRRC 539-03
- Status last verified
- Mar 2008
- First submitted
- 13 Sep 2005
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Of Safety And Effectiveness For Depakote ER In Pediatric Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00199966
- Acronym / sponsor ID
- CHW 03/163, HRRC 539-03
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder; Pediatric Bipolar Disorder; Depakote ER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Nov 2005 (actual)
- First posted
- 20 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 research is to compare how safely and how well this medicine works in treating children and teenagers between the ages of 6 and 17 years with a diagnosis of Bipolar Disorder.
Detailed description
There is no accepted, well-studied treatment for Pediatric Bipolar Disorder and treatment has often followed from adult studies. The primary objectives for this study are to determine if subjects can safely and easily be switched from divalproex sodium to Depakote ER and to determine if Depakote ER is both safe and effective for pediatric patients with Bipolar I or II. Secondary objectives include determining the serum levels of valproic acid 20 hours after administration of Depakote ER at a steady rate and determining if co-administration of stimulants will effect the serum levels of valproic acid. Thirty subjects, ages 6-17 years, with a diagnosis of Bipolar I or II who are currently asymptomatic, according to a score of less than 10 on the Young Mania Rating Scale, or who desire to change to once daily dosing, or desire to change because of the likelihood of decreased side-effects, will be recruited from our clinic and the community. If subjects have completed baseline evaluations (including diagnostic confirmation), labs, and rating scales and are still eligible to participate, subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex sodium extended release (DVP ER).
The potential benefits of the research are that new information will be added to the field of child and adolescent psychiatry and the possibility that the medication change may result in improved symptoms of mania or side effects of medications related to peak and trough levels. The potential benefits of this study outweigh the possible risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of Bipolar I or II confirmed by K-SADS and clinical interview.
- Ages 6 to 17 years 11 months.
- YMRS score of <10, this is consistent with minimal symptoms of mania. Or a desire to change medications due to a simplified dosing schedule or to reduce unwanted side effects of divalproex sodium.
- Ability and willingness of subject and parent(s)/guardian(s) to provide informed written assent/consent.
Key exclusion criteria (11 listed)
- Diagnosis of: Pervasive Developmental Disorders, Schizophrenia spectrum disorders, Obsessive Compulsive Disorder.
- Concurrent medical conditions requiring medication or that are unstable.
- Current suicidal thoughts.
- Recent suicidal behavior.
- Pregnancy or sexually active female not using a reliable form of contraception.
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 extended release | Drug | – |
Primary outcome
Young Mania Rating Scale (YMRS), rate at baseline, Week 2,4,6,&8
5 secondary outcomes
Kiddie version of the Schedule for Affective Disorders and Schizophrenia (KSADS), assessed at baseline only.
Child Depression Rating Scale (CDRS), rate at baseline through Week 8.
Clinical Global Impression: Improvement and Severity (CGI), for mania, depression and ADHD. Rate from baseline through Week 8.
Conner's Parent and Teacher Rating Scales (CRS). Rate from baseline through Week 8.
Side Effect For Children & Adolescents (SEFCA). Rate from baseline through Week 8.
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 7 Mar 2008.
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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.
Russell E Scheffer, MD principal investigator
Medical College of Wisconsin; Children's Hospital of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Divalproex sodium extended release in people with Bipolar Disorder, run by Medical College of Wisconsin 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 4 inclusion and 11 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 7 Mar 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Young Mania Rating Scale (YMRS), rate at baseline, Week 2,4,6,&8. 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 7 Mar 2008.