Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
161 participants
INTERVENTIONAL
2006-07-31
2007-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder
NCT02623504
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
NCT00150553
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
NCT00181844
A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
NCT00195780
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
NCT00067262
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Equetro active
Extended-Release Carbamazepine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Extended-Release Carbamazepine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. A lifetime history of bipolar disorder symptoms for at least 2 months.
3. YMRS score greater than or equal to 16.
4. CGI-S score greater than or equal to 4.
5. Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
6. Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
7. 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.
8. Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.
Exclusion Criteria
2. A history of lack of therapeutic response or hypersensitivity to the study drug.
3. A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
4. Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
5. A history of aplastic anemia, agranulocytosis or bone marrow depression.
6. A history of seizure disorder, other than a single childhood febrile seizure.
7. A history of severe, unstable asthma.
8. Current hospitalization for psychiatric symptoms.
9. History of alcohol or other substance abuse or dependence.
10. Pregnant or lactating females.
11. Body weight less than or equal to 25 kg.
10 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Validus Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
11 Shire Clinical Research Site
Altamonte Springs, Florida, United States
17 Segal Institute for Clinical Research
Fort Lauderdale, Florida, United States
19 Sarkis Clinical Trials
Gainesville, Florida, United States
23 Shire Clinical Research Site
Jacksonville, Florida, United States
21 Scientific Clinical Research
North Miami, Florida, United States
14 Northlake Medical Research
Decatur, Georgia, United States
04 Mountain West Clinical Trials
Eagle, Idaho, United States
25 Capstone Clinical Research
Libertyville, Illinois, United States
15 Psychiatric Associates
Overland Park, Kansas, United States
27 Owensboro Behavioral Care
Owensboro, Kentucky, United States
05 Brentwood Research Institute
Shreveport, Louisiana, United States
13 Pharmasite Research, Inc
Baltimore, Maryland, United States
02 Finger Lakes Clinical Research
Rochester, New York, United States
01 Nccacrf
Chapel Hill, North Carolina, United States
06 University of Cincinnati, College of Medicine
Cincinnati, Ohio, United States
09 Discovery and Wellness Center for Children
Cleveland, Ohio, United States
03 IPS Research
Oklahoma City, Oklahoma, United States
26 Suburban Research Associates
Media, Pennsylvania, United States
12 Claghorn-Lesem Research Clinic
Bellaire, Texas, United States
07 Center for Pediatric Psychiatry
Dallas, Texas, United States
24 Red Oak Psychiatry Associates
Houston, Texas, United States
10 RID Clinical Research, Inc
Lake Jackson, Texas, United States
08 Dominion Clinical Research
Midlothian, Virginia, United States
22 Brighton Research Group
Virginia Beach, Virginia, United States
20 Shire Clinical Research Site
Milwaukee, Wisconsin, United States
16 Rogers Center for Research and Training
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPD417-311
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.