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An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Divalproex Sodium (Depakote ER)
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder (manic or mixed type)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA Current primary diagnosis of bipolar I disorder, mania or mixed type Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score >= 18 Hospitalized no more than 7 days at time of Screening or in process of being admitted History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement EXCLUSION CRITERIA History of schizophrenia or schizoaffective disorder Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids) Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania) Had first manic episode after age 60 Has ever taken clozapine Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines History of active alcohol or substance dependence within past 3 months. History of failed treatment on adequate valproate therapy for bipolar disorder Has taken Depakote (DR or ER) regularly over the last 30 days Has serious violent, homicidal, or suicidal ideation

Sites / Locations

  • Comprehensive Neuroscience of SCA
  • AVI Clinical Research
  • Washington Hospital Center
  • Mark Lerman, MD
  • University of Louisville Bipolar Research Program
  • Brentwood Research Inst.
  • Centers for Behavioral Health, LLC
  • McLean Hospital
  • Pioneer Research
  • University of Mississippi Medical Center
  • Steven A. Glass, MD
  • The Holliswood Hospital
  • NYU School of Medicine - Bellevue
  • MetroHealth Medical Center
  • UT Mental Sciences Institute
  • San Antonio State Hospital
  • CNS of Northern Virginia
  • VAMC

Outcomes

Primary Outcome Measures

Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.

Secondary Outcome Measures

Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.

Full Information

First Posted
May 15, 2003
Last Updated
August 2, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00060905
Brief Title
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Official Title
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder (manic or mixed type)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
370 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium (Depakote ER)
Primary Outcome Measure Information:
Title
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
Secondary Outcome Measure Information:
Title
Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
Title
BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Current primary diagnosis of bipolar I disorder, mania or mixed type Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score >= 18 Hospitalized no more than 7 days at time of Screening or in process of being admitted History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement EXCLUSION CRITERIA History of schizophrenia or schizoaffective disorder Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids) Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania) Had first manic episode after age 60 Has ever taken clozapine Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines History of active alcohol or substance dependence within past 3 months. History of failed treatment on adequate valproate therapy for bipolar disorder Has taken Depakote (DR or ER) regularly over the last 30 days Has serious violent, homicidal, or suicidal ideation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information - Abbott
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Neuroscience of SCA
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
AVI Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mark Lerman, MD
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
University of Louisville Bipolar Research Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Brentwood Research Inst.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Centers for Behavioral Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Pioneer Research
City
Baltimore
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Steven A. Glass, MD
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
The Holliswood Hospital
City
Holliswood
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Facility Name
NYU School of Medicine - Bellevue
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
UT Mental Sciences Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio State Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78223
Country
United States
Facility Name
CNS of Northern Virginia
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
VAMC
City
MIlwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20361904
Citation
Hirschfeld RM, Bowden CL, Vigna NV, Wozniak P, Collins M. A randomized, placebo-controlled, multicenter study of divalproex sodium extended-release in the acute treatment of mania. J Clin Psychiatry. 2010 Apr;71(4):426-32. doi: 10.4088/JCP.08m04960yel. Epub 2010 Mar 9.
Results Reference
derived
PubMed Identifier
17107240
Citation
Bowden CL, Swann AC, Calabrese JR, Rubenfaer LM, Wozniak PJ, Collins MA, Abi-Saab W, Saltarelli M; Depakote ER Mania Study Group. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry. 2006 Oct;67(10):1501-10. doi: 10.4088/jcp.v67n1003.
Results Reference
derived

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An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

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