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

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Divalproex Sodium Extended-Release Tablets Drug: Olanzapine Drug: Risperidone	Phase II

MedlinePlus related topics:

Schizophrenia

Drug Information available for:

Risperidone Divalproex sodium Valproate Sodium Valproic acid Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Abbott:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073164

Show 35 Study Locations

Sponsors and Collaborators

Abbott

Investigators


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

More Information

Study ID Numbers:	M02-547
First Received:	November 17, 2003
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00073164
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia

Dopamine

Mental Disorders

Risperidone

Olanzapine

Psychotic Disorders

Valproic Acid

Serotonin

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Dopamine Antagonists

Enzyme Inhibitors

Antipsychotic Agents

Antimanic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Antagonists

Serotonin Agents

Autonomic Agents

Therapeutic Uses

GABA Agents

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on November 19, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00073164