Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Los Angeles, California


Purpose:

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.


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


NCT ID:

NCT00073164


Primary Contact:

Study Director
Global Medical Information 800-633-9110
Abbott


Backup Contact:

N/A


Location Contact:

Los Angeles, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.