Bipolar I DisorderPhase 3NCT00195780
A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
A Phase 3 study testing Divalproex Sodium (Depakote ER) in people with Bipolar I Disorder, run by Abbott at 29 sites in United States.
Trial summary
The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Divalproex Sodium (Depakote ER)
- How many people
- 227 participants
- Where
- 29 sitesUnited States
- Study dates
- Feb 2005to not given
- Phase
- Phase 3
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is between 10 and 17 years of age, inclusive, on Day 1 and weighs at least 60 lbs (27 kg).
- Subject has a current psychiatric diagnosis of bipolar I disorder, manic or mixed episode, based on the K-SAD-PL interview and DSM-IV-TR criteria.
- Subject is an outpatient in a manic or mixed episode with a YMRS score of greater than or equal to 16 during Screening and at Day 1.
Who cannot join
- Has an Axis I disorder other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder, Enuresis, Encopresis, Parasomnias, Agoraphobia, Specific Phobia, Social Phobia or Separation Anxiety Disorder; or subject has an Axis II disorder that would interfere with the subject's ability to comply with study procedures or confound interpretation of the study results. Subject meets DSM-IV-TR criteria for substance abuse within the month prior to Screening, or meets the criteria for substance dependence within the three months prior to Screening, or exhibits signs of drug or alcohol intoxication or withdrawal at Day 1.
- Is expected to require hospitalization for the current manic or mixed episode.
- Is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others.
- Has a history of a chronic or acute medical disorder that, in the opinion of the investigator, would preclude compliance with the protocol, or confound interpretation of the study results.
- Has a history of, or is suspected of having a seizure disorder.
- Has any central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease.
Show all 10Show fewer
- Has Platelet count less than or equal to 100,000/µL
- Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening.
- Is taking a protocol allowed medication for ADHD that has not been stable for at least 3 months prior to Day 1, or that, in the investigator's opinion, may be exacerbating mood symptoms.
- Requires anticoagulant drug therapy.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Altamonte Springs, Florida, 32701
Clinical Trials Specialists
Bala-Cynwyd, Pennsylvania, 19004-1604
Pharmasite Research
Baltimore, Maryland, 21208
Acadia Hospital
Bangor, Maine, 04402-0422
Northwest Clinical Research Center
Bellevue, Washington, 98004
Neuro Behavioral Clinical Research, INC.
Canton, Ohio, 44708
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, 27514
Psychiatric Professional Services
Cincinnati, Ohio, 45267-0559
Northlake Medical Research Center
Decatur, Georgia, 30033
InSite Clinical Research
DeSoto, Texas, 75115
Mountain West Clinical Trials
Eagle, Idaho, 83616
Odyssey Research
Fargo, North Dakota, 58104
Segal Institute for Clinical Research
Fort Lauderdale, Florida, 33319
Sarkis Clinical Trials
Gainesville, Florida, 32607
Red Oak Psychiatry
Houston, Texas, 77090
R/D Clinical Research
Lake Jackson, Texas, 77566
Capstone Clinical Research
Libertyville, Illinois, 60048
Rakesh Ranjan, M.D. & Associates, Inc.
Lyndhurst, Ohio, 44124
UTHSC, Sept. of Psychiatry, College of Medicine
Memphis, Tennessee, 38105
Cientifica Inc.
Newton, Kansas, 67114
Segal Institute for Clinical Research
North Miami, Florida, 33161
IPS Research
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73120
Psychiatric Associates
Overland Park, Kansas, 66211
PCSD Feighner Research
San Diego, California, 92111
PCSD Feighner Research
San Marcos, California, 92078
Brentwood Research Institute
Shreveport, Louisiana, 71101
Clinco
Terre Haute, Indiana, 47802
Kolin Research Group
Winter Park, Florida, 32789
About this study
Official title: An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.
- Conditions
- Bipolar I Disorder
- Being tested
- Divalproex Sodium (Depakote ER)
- Keywords
- Bipolar I Disorder, Depakote
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium (Depakote ER)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Secondary outcomes (7)
Y-MRS
CGI-S
C-GAS
CDRS-R
CGSQ
responders
remitters
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 startFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195780
- Sponsor's protocol ID
- M03-647
- Status last verified
- Jun 2007
- First submitted
- 14 Sep 2005
- Last updated
- 2 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00195780
- Acronym / sponsor ID
- M03-647
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder, Depakote
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- 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 the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject is between 10 and 17 years of age, inclusive, on Day 1 and weighs at least 60 lbs (27 kg).
- Subject has a current psychiatric diagnosis of bipolar I disorder, manic or mixed episode, based on the K-SAD-PL interview and DSM-IV-TR criteria.
- Subject is an outpatient in a manic or mixed episode with a YMRS score of greater than or equal to 16 during Screening and at Day 1.
Key exclusion criteria (10 listed)
- Has an Axis I disorder other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder, Enuresis, Encopresis, Parasomnias, Agoraphobia, Specific Phobia, Social Phobia or Separation Anxiety Disorder; or subject has an Axis II disorder that would interfere with the subject's ability to comply with study procedures or confound interpretation of the study results. Subject meets DSM-IV-TR criteria for substance abuse within the month prior to Screening, or meets the criteria for substance dependence within the three months prior to Screening, or exhibits signs of drug or alcohol intoxication or withdrawal at Day 1.
- Is expected to require hospitalization for the current manic or mixed episode.
- Is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others.
- Has a history of a chronic or acute medical disorder that, in the opinion of the investigator, would preclude compliance with the protocol, or confound interpretation of the study results.
- Has a history of, or is suspected of having a seizure disorder.
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 ER) | Drug | – |
Primary outcome
Safety
7 secondary outcomes
Y-MRS
CGI-S
C-GAS
CDRS-R
CGSQ
responders
remitters
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 2 Jul 2007.
Related trials for Bipolar I Disorder
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
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.
Global Medical Information study director
Abbott
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divalproex Sodium (Depakote ER) in people with Bipolar I Disorder, run by Abbott at 29 sites 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 3 inclusion and 10 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 2 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety. 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 2 Jul 2007.