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

Tracking Information

First Received Date ^ICMJE

November 17, 2003

Last Updated Date

August 2, 2006

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00073164 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Divalproex Sodium Extended-Release Tablets
Drug: Olanzapine
Drug: Risperidone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00073164

Responsible Party

Study ID Numbers ^ICMJE

M02-547

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Medical Information 800-633-9110

Abbott

Information Provided By

Abbott

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP