Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2003-12-31

Brief Summary

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The purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Olanzapine Hydrochloride

Intervention Type DRUG

Risperidone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, aged 18 - 60
* Subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to DSM-IV
* Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
* BPRS total score (1 to 7 scale) of greater than or equal to 36 at visit 1
* Subjects must have a minimum total score of greater than or equal to 14 on the five items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications

Exclusion Criteria

* Treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
* Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
* Electroconvulsive therapy (ECT) within 1 month (90 days) prior to study entry (visit 1)
* Treatment with remoxipride within 6 months (180 days) prior to visit 1
* Documented history of allergic reaction to study medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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F1D-GH-S036

Identifier Type: -

Identifier Source: secondary_id

6704