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

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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


  Show 35 Study Locations
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     History of Changes
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
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
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