NCT00103571

Brief Summary

The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Jul 2004

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 6, 2007

Status Verified

November 1, 2007

First QC Date

February 10, 2005

Last Update Submit

November 5, 2007

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

  • The primary objective of this study is to test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the

  • Positive and Negative Syndrome Scale Excited Component (PANSS-EC) over 5 days of treatment (4 continuous 24 hr treatment exposures). The null hypothesis of the study is that there is no difference between olanzapine and

  • aripiprazole in reducing agitation.

Secondary Outcomes (18)

  • The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);

  • The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);

  • The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of

  • the PANSS_EC from baseline;

  • The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);

  • +13 more secondary outcomes

Interventions

OlanzapineDRUG
AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
  • Patients must be agitated
  • Patients must display psychotic symptoms
  • Patients must be inpatients who are expected to stay in the hospital for at least 5 days
  • Patients must be 18 to 55 years of age

You may not qualify if:

  • Patients may not be hospitalized for greater than 72 hours prior to study start
  • Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
  • Patients may not be actively suicidal
  • Patients may not be diagnosed with substance-induced psychosis or substance dependence
  • Patients may not have acute, serious, or unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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. test

Saint Charles, Missouri, 63301, United States

Location

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. test

Beachwood, Ohio, 44122, United States

Location

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. test

Canton, Ohio, 44708, United States

Location

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. test

Memphis, Tennessee, 38117, United States

Location

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. test

Rio Piedras, 00926, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

OlanzapineAripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperazinesHeterocyclic Compounds, 1-RingQuinolonesQuinolines

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2005

First Posted

February 11, 2005

Study Start

July 1, 2004

Study Completion

August 1, 2006

Last Updated

November 6, 2007

Record last verified: 2007-11

Locations

PR(1)US(4)