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OpenTrials
Completed

NCT Number: NCT00000374

Treatment for First-Episode Schizophrenia

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

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Key information

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hillside Hospital, Glen Oaks, New York, United States

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About this study

The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone.

Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another.

First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00320671

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion criteria

  • Prior treatment with antipsychotic medications.

Treatment and study plan

Olanzapine

Drug

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.

Risperidone

Drug

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.

Primary outcomes

  1. Treatment response

    Time frame: 8 consecutive weeks

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • The Zucker Hillside Hospital

Registry information

Official study title

Preventing Morbidity in First-Episode Schizophrenia

Important dates

Study start
1998
Primary completion
2007
Study completion
2007
First posted
Nov 3, 1999
Registry last updated
Jan 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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