An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00067262 |
Recruitment Status :
Completed
First Posted : August 15, 2003
Last Update Posted : August 4, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder | Drug: Divalproex Sodium Extended-Release Tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | March 2003 |

- Change from baseline to the final evaluation in Y-MRS score.
- Vital signs
- Adverse events

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Ages Eligible for Study: | 10 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067262
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 |
Study Director: | Global Medical Information | Abbott |
ClinicalTrials.gov Identifier: | NCT00067262 |
Other Study ID Numbers: |
M01-342 |
First Posted: | August 15, 2003 Key Record Dates |
Last Update Posted: | August 4, 2006 |
Last Verified: | August 2006 |
Bipolar Disorder Type 1 (manic or mixed type) |
Disease Bipolar Disorder Pathologic Processes Bipolar and Related Disorders Mental Disorders Valproic Acid Anticonvulsants 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 |