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Treatment for First-Episode Schizophrenia

Preventing Morbidity in First-Episode Schizophrenia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000374
Enrollment
125
Registered
1999-11-03
Start date
1998-09-30
Completion date
2007-05-31
Last updated
2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Adolescence, Adult, Antipsychotic Agents, Female, Human, Male, olanzapine, Risperidone, Schizophrenia, Antipsychotic Agents -- *therapeutic use, olanzapine -- *therapeutic use, Risperidone -- *therapeutic use, Schizophrenia -- *drug therapy

Brief summary

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

Detailed description

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

Interventions

DRUGOlanzapine

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.

DRUGRisperidone

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
The Zucker Hillside Hospital
CollaboratorOTHER
Northwell Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion criteria

* Prior treatment with antipsychotic medications.

Design outcomes

Primary

MeasureTime frame
Treatment response8 consecutive weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026