NCT00337662

Brief Summary

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
628

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
3 countries

34 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

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 4, 2009

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

June 14, 2006

Results QC Date

December 3, 2008

Last Update Submit

February 8, 2010

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients

    Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).

    Weeks 0, 3, 4, 6, 8, 12

Secondary Outcomes (17)

  • Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients

    Weeks 2, 3, 4, 6, 8, 12

  • The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score

    Week 0 to Week 12

  • The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score

    Week 0 to Week 12

  • Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission

    Week 0 to Week 12

  • Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission

    Week 2 to Week 12

  • +12 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Olanzapine for Not Early Onset response (NEO) patients

Drug: olanzapine

2

ACTIVE COMPARATOR

Risperidone for Not Early Onset response (NEO) patients

Drug: risperidone

3

ACTIVE COMPARATOR

Risperidone for Early Onset response (EO) patients

Drug: risperidone

Interventions

olanzapineDRUG

10-20 milligrams (mg), oral, daily, 10 weeks.

Also known as: LY170053, Zyprexa
1
risperidoneDRUG

2-6 mg, oral, daily, for 10 weeks.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill.
  • Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
  • Patients in whom a switch to another antipsychotic medication is acutely indicated.

You may not qualify if:

  • Patients who are deemed nonresponsive to risperidone or olanzapine.
  • Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1.
  • Patients having received olanzapine or risperidone in the past 30 days.
  • Treatment with clozapine within 1 year prior to Visit 1.
  • Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).
  • A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

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.

Little Rock, Arkansas, 72201, United States

Location

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Escondido, California, 92025, United States

Location

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Garden Grove, California, 92845, United States

Location

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Glendale, California, 91206, United States

Location

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National City, California, 91950, United States

Location

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Orange, California, 92868, United States

Location

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San Diego, California, 92123, United States

Location

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Santa Ana, California, 92701, United States

Location

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Washington D.C., District of Columbia, 20016, United States

Location

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Fort Lauderdale, Florida, 33319, United States

Location

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Hialeah, Florida, 33016, United States

Location

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Chicago, Illinois, 60640, United States

Location

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Paducah, Kentucky, 42003, United States

Location

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Lake Charles, Louisiana, 70601, United States

Location

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Boston, Massachusetts, 02118, United States

Location

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Jackson, Mississippi, 39216, United States

Location

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Kansas City, Missouri, 64108, United States

Location

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Omaha, Nebraska, 68133, United States

Location

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Clementon, New Jersey, 08021, United States

Location

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Cedarhurst, New York, 11516, United States

Location

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Olean, New York, 14760, United States

Location

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Staten Island, New York, 10312, United States

Location

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Toledo, Ohio, 43623, United States

Location

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Philadelphia, Pennsylvania, 19131, United States

Location

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Rapid City, South Dakota, 57701, United States

Location

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Memphis, Tennessee, 38117, United States

Location

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Austin, Texas, 78754, United States

Location

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Arlington, Virginia, 22201, United States

Location

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Portsmouth, Virginia, 23703, United States

Location

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Richmond, Virginia, 23298, United States

Location

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Kirkland, Washington, 98033, United States

Location

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Buenos Aires, C1062ABF, Argentina

Location

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Khot'kovo, 127025, Russia

Location

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Moscow, 115522, Russia

Location

Related Publications (4)

  • Chen L, Phillips G, Johnston J, Kinon BJ, Ascher-Svanum H, Kollack-Walker S, Succop P, Naber D. The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial. BMC Psychiatry. 2011 Dec 28;11:203. doi: 10.1186/1471-244X-11-203.

    PMID: 22204569DERIVED

  • Fijal BA, Stauffer VL, Kinon BJ, Conley RR, Hoffmann VP, Witte MM, Zhao F, Houston JP. Analysis of gene variants previously associated with iloperidone response in patients with schizophrenia who are treated with risperidone. J Clin Psychiatry. 2012 Mar;73(3):367-71. doi: 10.4088/JCP.10m06507. Epub 2011 Jul 12.

    PMID: 21813073DERIVED

  • Ascher-Svanum H, Nyhuis AW, Stauffer V, Kinon BJ, Faries DE, Phillips GA, Schuh K, Awad AG, Keefe R, Naber D. Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives. Curr Med Res Opin. 2010 Oct;26(10):2403-10. doi: 10.1185/03007995.2010.515900.

    PMID: 20812791DERIVED

  • Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Zhou W, Kapur S, Kane JM. Early response to antipsychotic drug therapy as a clinical marker of subsequent response in the treatment of schizophrenia. Neuropsychopharmacology. 2010 Jan;35(2):581-90. doi: 10.1038/npp.2009.164.

    PMID: 19890258DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

OlanzapineRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
1-800-545-5979

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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 17, 2010

Results First Posted

August 4, 2009

Record last verified: 2010-02

Locations

US(31)RU(2)AR(1)