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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060905
• Other study ID #: M02-540
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2003
• Last updated: August 2, 2006
• Start date: January 2003

Study information

• Verified date: August 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Divalproex Sodium (Depakote ER)

Locations

Country	Name	City	State
United States	Pioneer Research	Baltimore	Michigan
United States	McLean Hospital	Belmont	Massachusetts
United States	Comprehensive Neuroscience of SCA	Cerritos	California
United States	Steven A. Glass, MD	Clementon	New Jersey
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	CNS of Northern Virginia	Falls Church	Virginia
United States	Mark Lerman, MD	Hoffman Estates	Illinois
United States	The Holliswood Hospital	Holliswood	New York
United States	UT Mental Sciences Institute	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Louisville Bipolar Research Program	Louisville	Kentucky
United States	VAMC	MIlwaukee	Wisconsin
United States	NYU School of Medicine – Bellevue	New York	New York
United States	Centers for Behavioral Health, LLC	Rockville	Maryland
United States	San Antonio State Hospital	San Antonio	Texas
United States	Brentwood Research Inst.	Shreveport	Louisiana
United States	AVI Clinical Research	Torrance	California
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
Secondary	Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
Secondary	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.