Completed

Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

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What is being tested

Aripiprazole

+ Aripiprazole
Drug
Who is being recruted

Schizophrenia

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 4
Interventional
Study Start: November 2003

See protocol details

Summary

Principal SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last updated: November 11, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Official TitleA Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia 
Principal SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last updated: November 11, 2013
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
370 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 effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

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.
Over 18 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

Inclusion Criteria: * Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
4 intervention groups 

are designated in this study

25% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
Group II
Active Comparator
Group III
Active Comparator
Group IV
Placebo
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 1 location
Suspended
Bristol-Meyers Squibb Call CenterWallingford, United StatesSee the location
CompletedOne Study Center