Bipolar I DisorderPhase 4NCT00350857
The Young Adult and Pediatric Bipolar Study
A Phase 4 study testing Extended-Release Carbamazepine in people with Bipolar I Disorder, run by Validus Pharmaceuticals at 26 sites in United States.
Trial summary
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder. 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?
- Extended-Release Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 26 sitesUnited States
- Study dates
- Jul 2006to Oct 2007
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.
- A lifetime history of bipolar disorder symptoms for at least 2 months.
- YMRS score greater than or equal to 16.
- CGI-S score greater than or equal to 4.
- Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
- Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
- The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.
- Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.
Who cannot join
- Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.
- A history of lack of therapeutic response or hypersensitivity to the study drug.
- A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
- Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
- A history of aplastic anemia, agranulocytosis or bone marrow depression.
- A history of seizure disorder, other than a single childhood febrile seizure.
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- A history of severe, unstable asthma.
- Current hospitalization for psychiatric symptoms.
- History of alcohol or other substance abuse or dependence.
- Pregnant or lactating females.
- Body weight less than or equal to 25 kg.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
11 Shire Clinical Research Site
Altamonte Springs, Florida, 32701
13 Pharmasite Research, Inc
Baltimore, Maryland, 21208
12 Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401
01 Nccacrf
Chapel Hill, North Carolina, 27514
06 University of Cincinnati, College of Medicine
Cincinnati, Ohio, 45267
09 Discovery and Wellness Center for Children
Cleveland, Ohio, 44106
07 Center for Pediatric Psychiatry
Dallas, Texas, 75235
14 Northlake Medical Research
Decatur, Georgia, 30333
04 Mountain West Clinical Trials
Eagle, Idaho, 83616
17 Segal Institute for Clinical Research
Fort Lauderdale, Florida, 33319
19 Sarkis Clinical Trials
Gainesville, Florida, 32607
24 Red Oak Psychiatry Associates
Houston, Texas, 77090
23 Shire Clinical Research Site
Jacksonville, Florida, 32256
10 RID Clinical Research, Inc
Lake Jackson, Texas, 77566
25 Capstone Clinical Research
Libertyville, Illinois, 60048
26 Suburban Research Associates
Media, Pennsylvania, 19063
08 Dominion Clinical Research
Midlothian, Virginia, 23112
20 Shire Clinical Research Site
Milwaukee, Wisconsin, 53201
16 Rogers Center for Research and Training
Milwaukee, Wisconsin, 53227
21 Scientific Clinical Research
North Miami, Florida, 33161
03 IPS Research
Oklahoma City, Oklahoma, 73103
15 Psychiatric Associates
Overland Park, Kansas, 66211
27 Owensboro Behavioral Care
Owensboro, Kentucky, 42303
02 Finger Lakes Clinical Research
Rochester, New York, 14618
05 Brentwood Research Institute
Shreveport, Louisiana, 71101
22 Brighton Research Group
Virginia Beach, Virginia, 23452
About this study
Official title: A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
- Conditions
- Bipolar I Disorder
- Being tested
- Extended-Release Carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release CarbamazepineDrug
| Study group | Role | What they receive |
|---|---|---|
| Equetro active | Active comparator | Not described Receives: Drug: Extended-Release Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment.
Measured: 6 months
Secondary outcomes (1)
Reduction of bipolar symptoms as assessed by the Young Mania Rating Scale (YMRS), Clinical Global Impressions Scale (CGI) and Children's Depression Rating Scale (CDRS-S) after 6 months of treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2007
- Study completionOct 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Validus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350857
- Sponsor's protocol ID
- SPD417-311
- Status last verified
- Nov 2009
- First submitted
- 10 Jul 2006
- Last updated
- 20 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.
- ClinicalTrials.gov ID
- NCT00350857
- Acronym / sponsor ID
- SPD417-311
- Conditions
- Bipolar I Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Validus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Jul 2006 (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.
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Equetro active | Active comparator | Drug: Extended-Release Carbamazepine |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
Key exclusion criteria (11 listed)
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 |
|---|---|---|
| Extended-Release Carbamazepine | Drug | Equetro active |
Primary outcome
Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment.
Time frame: 6 months
1 secondary outcome
Reduction of bipolar symptoms as assessed by the Young Mania Rating Scale (YMRS), Clinical Global Impressions Scale (CGI) and Children's Depression Rating Scale (CDRS-S) after 6 months of treatment.
Time frame: 6 months
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 20 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extended-Release Carbamazepine in people with Bipolar I Disorder, run by Validus Pharmaceuticals at 26 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 8 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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 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?
Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment. (time frame: 6 months). 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 20 Feb 2014.