Clinical trial NCT00073164: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-11-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
Secondary outcomes:
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).
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Gainsville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Rockville
country: United States
state: Maryland
city: Jackson
country: United States
state: Mississippi
city: Clementon
country: United States
state: New Jersey
city: Kenilworth
country: United States
state: New Jersey
city: Holliswood
country: United States
state: New York
city: New York
country: United States
state: New York
city: Butner
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
Study officials:
affiliation: Abbott
name: Global Medical Information 800-633-9110
role: STUDY_DIRECTOR
References: