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

Abbott

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: Olanzapine

Drug: Risperidone

Drug: Divalproex Sodium Extended-Release Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00073164

M02-547

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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