Clinical Trial: An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

This study is currently recruiting patients.

Sponsored by: Abbott Laboratories
Information provided by: Abbott Laboratories

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 Treatment or Intervention Phase
Bipolar Disorder
 Drug: Divalproex Sodium Extended-Release Tablets
Phase III

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

KEY 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

KEY EXCLUSION CRITERIA

  • Axis I other than Attention Deficit Hyperactiviy 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

Location and Contact Information


California
      Stanford University, Stanford,  California,  94304,  United States; Recruiting
Meghan Howe  650-736-2688    meghowe@stanford.edu 
Kiki Chang, M.D.,  Principal Investigator

District of Columbia
      Childrens National Medical Center, Washington,  District of Columbia,  20010,  United States; Recruiting
Karen Seymour  202-884-4261    kseymour@cnmc.org 
Adelaide Robb, M.D.,  Principal Investigator

Florida
      Altamonte Springs,  Florida,  32701,  United States; Recruiting
Brad Sushko, RN  407-830-0414    bsushko@cnsmail.com 
Ali Kashfi, M.D., P.A.,  Principal Investigator

      Destin,  Florida,  32541,  United States; Recruiting
Ron Simkin  850-243-9788    deb62288@aol.com 
Deborah Simkin, M.D., PA,  Principal Investigator

      Professional Clinical Research, Inc., Miami,  Florida,  33161,  United States; Recruiting
Antonio Spears  954-749-9229    aspears@segalinstitute.com 
Sohail Punjwani, MD,  Principal Investigator

      Segal Institute for Clinical Research, North Miami,  Florida,  33161,  United States; Recruiting
Alberta Nelson  954-605-3261    anelson@segalinstitute.com 
Scott Segal, M.D.,  Principal Investigator

Idaho
      Mountain West Clinical Trials, Boise,  Idaho,  83704,  United States; Recruiting
Joe Laragan, RN  208-672-8731    joe@mountainwestclinicaltrials.com 
William T Terry, M.D.,  Principal Investigator

Illinois
      Ingenium Clinical Research, Libertyville,  Illinois,  60031,  United States; Recruiting
Kelly Burns  847-549-7214    mgreenbaum@ingenium research.com 
Michael Greenbaum, MD,  Principal Investigator

Kansas
      Cientifica Inc at Praire View, Inc., Newton,  Kansas,  67114,  United States; Recruiting
Kendra Frey  316-284-6313    kendra.frey@cientifica.net 
Deborah Bergen, MD,  Principal Investigator

Kentucky
      Lexington,  Kentucky,  40509,  United States; Recruiting
Shannon Broughton  859-264-0045    scb@psychtrials.com 
Michael J Rieser, MD,  Principal Investigator

Louisiana
      LSU - Health Science Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Ann Layman  504-568-7901    alayma@lsuhsc.edu 
Pattie Jarrell  504-599-1128    pjarr1@lsuhsc.edu 
Humberto Quintana, M.D.,  Principal Investigator

      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
Jennifer Swanson  318-227-4565    jen@ brentwoodresearch.com 
Guy Brannon, MD,  Principal Investigator

Michigan
      New Oakland Child/Adoles and Family Center, Clinton Township,  Michigan,  United States; Recruiting
Kimberly Smith, MSW  586-412-5321  Ext. 310    ksmith@newoakland.org 
Ismail Sendi, M.D.,  Principal Investigator

Missouri
      Mercy Health Research, Chesterfield,  Missouri,  63017,  United States; Recruiting
Jennifer Daech  314-205-0007    daecjl@stlo.mercy.net 
David Duesenberg, M.D.,  Principal Investigator

Oklahoma
      Cutting Edge Research Group, Oklahoma City,  Oklahoma,  United States; Recruiting
Brooke Gwynn, BS  405-751-8113    brookegwynn@hotmail.com 
Willis Holloway, Jr., M.D.,  Principal Investigator

Texas
      University of Texas Medical Branch, Galveston,  Texas,  77705,  United States; Recruiting
Jennifer Bundens  800-236-2898    jrbunden@utmb.edu 
Karen Wagner, M.D., Ph.D,  Principal Investigator

      University of Texas Medical Branch, Houston,  Texas,  77058,  United States; Recruiting
Nikki Amaratunge, MA  800-236-2898 
Karen Wawner, M.D., Ph.D,  Principal Investigator

More Information

Study ID Numbers:  M01-342
Record last reviewed:  January 2005
Last Updated:  January 10, 2005
Record first received:  August 13, 2003
ClinicalTrials.gov Identifier:  NCT00067262
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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