Clinical trial NCT00060905: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder (manic or mixed type)
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-05-16
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
Secondary outcomes:
measure: Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
measure: 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.
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Comprehensive Neuroscience of SCA
state: California
city: Torrance
country: United States
facility: AVI Clinical Research
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Hoffman Estates
country: United States
facility: Mark Lerman, MD
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Bipolar Research Program
state: Kentucky
city: Shreveport
country: United States
facility: Brentwood Research Inst.
state: Louisiana
city: Rockville
country: United States
facility: Centers for Behavioral Health, LLC
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Baltimore
country: United States
facility: Pioneer Research
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Clementon
country: United States
facility: Steven A. Glass, MD
state: New Jersey
city: Holliswood
country: United States
facility: The Holliswood Hospital
state: New York
city: New York
country: United States
facility: NYU School of Medicine - Bellevue
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Houston
country: United States
facility: UT Mental Sciences Institute
state: Texas
city: San Antonio
country: United States
facility: San Antonio State Hospital
state: Texas
city: Falls Church
country: United States
facility: CNS of Northern Virginia
state: Virginia
city: MIlwaukee
country: United States
facility: VAMC
state: Wisconsin
Study officials:
affiliation: Abbott
name: Global Medical Information - Abbott
role: STUDY_DIRECTOR
References:
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.
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.