Clinical trial NCT00000374: Treatment for First-Episode Schizophrenia
Official title: Preventing Morbidity in First-Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: The Zucker Hillside Hospital
First posted: 1999-11-03
Enrollment: 125
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion Criteria:

* Prior treatment with antipsychotic medications.

Primary outcomes:
measure: Treatment response
timeFrame: 8 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
city: Glen Oaks
country: United States
facility: Hillside Hospital
state: New York
Study officials:
affiliation: The Zucker Hillside Hospital
name: Delbert Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.