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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Comprehensive Neuroscience of SCA, Cerritos, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Divalproex Sodium (Depakote ER)

Drug

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start: 2003
First posted: May 16, 2003
Registry last updated: Aug 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed