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Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073164
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : August 4, 2006
Sponsor:
Information provided by:
Abbott

Brief Summary:
The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Divalproex Sodium Extended-Release Tablets Drug: Olanzapine Drug: Risperidone Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia
Study Start Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. The psychiatric rating scale battery will include the PANSS, the CGI Scale, and the CDSS. The NOSIE, Overall Treatment Evaluation, Burden Questionnaire, and Quality of Life Scale.

Secondary Outcome Measures :
  1. The movement rating scale battery will include the Simpson-Angus Scale (SAS), the Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

KEY INCLUSION CRITERIA:

  • Acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a PANNS Total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychosis cluster of the BPRS (extracted from the PANSS) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, conceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the BPRS (extracted from the PANSS): hostility and uncooperativeness or excitement and tension.
  • Current DSM-IV-TR diagnosis of schizophrenia as confirmed by the SCID
  • Positive response to antipsychotics in the previous 2 years

KEY EXCLUSION CRITERIA:

  • Current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode.
  • At the time of screening, has been hospitalized for more than 14 days for the current episode
  • Has ever taken clozapine
  • Has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months
  • Has serious violent, homicidal, suicidal ideation
  • Has received depot medications fluphenazine decanoate and/or haloperidol decanoate within 2 or 4 weeks prior to randomization respectively
  • Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
  • History of alcohol or substance dependence within the past month
  • Has taken any valproate product for a psychiatric indication within the previous 30 days
  • Has received an investigational drug within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073164


Locations
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United States, Alabama
Birmingham, Alabama, United States
Tuscaloosa, Alabama, United States
United States, California
Anaheim, California, United States
Cerritos, California, United States
Chula Vista, California, United States
Garden Grove, California, United States
Glendale, California, United States
Los Angeles, California, United States
San Diego, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Gainsville, Florida, United States
Melbourne, Florida, United States
North Miami, Florida, United States
Winter Park, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
South Bend, Indiana, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Maryland
Rockville, Maryland, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, New Jersey
Clementon, New Jersey, United States
Kenilworth, New Jersey, United States
United States, New York
Holliswood, New York, United States
New York, New York, United States
United States, North Carolina
Butner, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Falls Church, Virginia, United States
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Global Medical Information 800-633-9110 Abbott

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ClinicalTrials.gov Identifier: NCT00073164    
Other Study ID Numbers: M02-547
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: August 4, 2006
Last Verified: August 2006
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Valproic Acid
Olanzapine
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents