NCT00000374

Brief Summary

This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

2 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

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

8.7 years

First QC Date

November 2, 1999

Last Update Submit

January 12, 2012

Conditions

Schizophrenia

Keywords

AdolescenceAdultAntipsychotic AgentsFemaleHumanMaleolanzapineRisperidoneSchizophreniaAntipsychotic Agents -- *therapeutic useolanzapine -- *therapeutic useRisperidone -- *therapeutic useSchizophrenia -- *drug therapy

Outcome Measures

Primary Outcomes (1)

  • Treatment response

    8 consecutive weeks

Interventions

OlanzapineDRUG

The dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects.

RisperidoneDRUG

The dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects.

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

You may not qualify if:

  • Prior treatment with antipsychotic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Bronx-Lebanon Hospital Center

The Bronx, New York, 10456, United States

Location

Related Publications (1)

  • Gallego JA, Robinson DG, Sevy SM, Napolitano B, McCormack J, Lesser ML, Kane JM. Time to treatment response in first-episode schizophrenia: should acute treatment trials last several months? J Clin Psychiatry. 2011 Dec;72(12):1691-6. doi: 10.4088/JCP.10m06349. Epub 2011 Sep 6.

    PMID: 21939612DERIVED

MeSH Terms

Conditions

Schizophrenia

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

Study Officials

  • Delbert Robinson, MD

    The Zucker Hillside Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Delbert Robinson, MD/Prinicipal Investigator

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

September 1, 1998

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 13, 2012

Record last verified: 2012-01

Locations

US(2)