Completed

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

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What is being tested

Divalproex Sodium Extended-Release Tablets

+ Olanzapine
+ Risperidone
Drug
Who is being recruted

Schizophrenia

From 18 to 65 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2003

Summary

Principal SponsorAbbott
Last updated: August 4, 2006
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia 
Principal SponsorAbbott
Last updated: August 4, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
400 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 35 locations
Suspended
Unknown FacilityBirmingham, United StatesSee the location
Suspended
Unknown FacilityTuscaloosa, United States
Suspended
Unknown FacilityAnaheim, United States
Suspended
Unknown FacilityCerritos, United States

Completed35 Study Centers