Expired Study
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Anaheim, 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


Study is Available At:


Original ID:

M02-547


NCT ID:

NCT00073164


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

400


Enrollment Type:


Overall Contact Information

Official Name:Global Medical Information 800-633-9110
Study Director
Abbott

Study Dates

Start Date:July 2003
Verification Date:August 2006
Last Changed Date:August 2, 2006
First Received Date:November 17, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The movement rating scale battery will include the Simpson-Angus Scale (SAS), the Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS).
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Divalproex Sodium Extended-Release Tablets
Intervention Type:Drug
Name:Olanzapine
Intervention Type:Drug
Name:Risperidone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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