An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00067262
First received: August 13, 2003
Last updated: August 2, 2006
Last verified: August 2006
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Purpose
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Divalproex Sodium Extended-Release Tablets |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents |
Resource links provided by NLM:
Further study details as provided by Abbott:
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Outpatient between 10 and 17 years of age
- Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1
EXCLUSION CRITERIA
- Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism)
- Expected to require hospitalization for the current manic episode
- Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated
- Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms
- Unable to swallow tablets
- Has received depot psychoactive medication within one inter-injection interval of Day 1
- Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines
- History of alcohol or substance dependence within past 3 mos. or substance abuse within past month
- History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months
- Has taken Depakote (DR or ER) regularly for the current manic episode
- Has serious violent, homicidal, or suicidal ideation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067262
Locations
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94304 | |
| United States, District of Columbia | |
| Childrens National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Altamonte Springs, Florida, United States, 32701 | |
| Professional Clinical Research, Inc. | |
| Miami, Florida, United States, 33161 | |
| Segal Institute for Clinical Research | |
| North Miami, Florida, United States, 33161 | |
| United States, Idaho | |
| Mountain West Clinical Trials | |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| Capstone Clinical Research | |
| Libertyville, Illinois, United States, 60031 | |
| United States, Kansas | |
| Cientifica Inc at Praire View, Inc. | |
| Newton, Kansas, United States, 67114 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Louisiana | |
| LSU - Health Science Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Brentwood Research Institute | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Michigan | |
| New Oakland Child/Adoles and Family Center | |
| Clinton Township, Michigan, United States | |
| United States, Missouri | |
| Mercy Health Research | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Oklahoma | |
| Cutting Edge Research Group | |
| Oklahoma City, Oklahoma, United States | |
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77705 | |
| University of Texas Medical Branch | |
| Houston, Texas, United States, 77058 | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Global Medical Information | Abbott |
More Information
No publications provided by Abbott
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00067262 History of Changes |
| Other Study ID Numbers: | M01-342 |
| Study First Received: | August 13, 2003 |
| Last Updated: | August 2, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
|
Bipolar Disorder Type 1 (manic or mixed type) |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Valproic Acid Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013