Bipolar I Disorder, Manic or Mixed Clinical Trial
Official title:
An Open-Label Long-Term Study to Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
| NCT number | NCT00195767 |
| Other study ID # | M02-555 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 14, 2005 |
| Last updated | March 17, 2007 |
| Start date | July 2004 |
| Verified date | March 2007 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 10 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed. - The subject was randomized into Study M01-342 and either completed the study or prematurely discontinued due to ineffectiveness. - The subject is male or a non-pregnant, non-lactating female. - Subject is judged to be in general good health based upon the results of a physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory profile (as described in Section 5.3.1) Exclusion Criteria - Subject is female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives). - Subject experienced a serious adverse event in Study M01-342, which the investigator considered "possibly" or "probably related" to study drug. - Subject 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. - Subject has any of the following abnormal laboratory results at the last assessment prior to Day 1: Platelet count </= 100,000/µL; ALT or AST >/= 2 times Upper Limit of Normal (ULN) - The subject is taking a protocol allowed medication for ADHD that has not been stable for at least 3 months prior to Day 1, is expected to require a dosage adjustment during the study, or that, in the investigators opinion, may be exacerbating mood symptoms. - Subject requires treatment with or has taken a protocol-prohibited medication (see Appendix D) within 5 elimination half lives of Day 1. - Subject has received an investigational drug, other than Depakote ER in Study M01-342, within 30 days prior to Day 1 of this study. - In the investigator's opinion, long-term treatment with Depakote ER for the subject's mania associated with bipolar disorder is contraindicated. - For any reason, subject is considered by the investigator to be an unsuitable candidate for this study. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Global Medical Information-Abbott | North Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety outcome measures | |||
| Secondary | Y-MRS | |||
| Secondary | CGI-S | |||
| Secondary | C-GAS | |||
| Secondary | CDRS-R | |||
| Secondary | CGSQ | |||
| Secondary | responders | |||
| Secondary | remitters |