Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia

NCT02192723

Schizophrenia

COMPLETED NA

Effectiveness of Ziprasidone for Patients With Schizophrenia

NCT01198353

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE4

Safety and Efficacy of Seroquel in First Episode Schizophrenia

NCT00254241

Schizophrenia

COMPLETED PHASE4

An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia

NCT01299389

Schizophrenia

COMPLETED PHASE3

Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients

NCT00921804

Schizophrenia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizophreniform Disorder Schizoaffective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A-prexa

A-prexa 5, 10mg

Group Type EXPERIMENTAL

Zyprexa

Intervention Type DRUG

Zyprexa 5-20 mg for 6 weeks

Zyprexa

Zyprexa 5, 10mg

Group Type ACTIVE_COMPARATOR

A-prexa

Intervention Type DRUG

A-prexa 5-20 mg for 6 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

A-prexa

A-prexa 5-20 mg for 6 weeks

Intervention Type DRUG

Zyprexa

Zyprexa 5-20 mg for 6 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 20 years to 65 years
* Schizophrenia patient with an acute exacerbation
* Understand the requirement of the study and voluntarily consent to participate in the study

Exclusion Criteria

* Patients who have another psychiatric disorders
* Patients who have unstable medical conditions
* Patients who have clinically important abnormalities of liver function test (\>2.5 fold of upper normal limit), ECG and vital sign at screening visit
* Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
* Patients who have a history of an allergic reaction to olanzapine
* Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.
* Patient who take clozapine within 12 weeks before screening visit

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No