Treatment for First-Episode Schizophrenia

• ClinicalTrials.gov Identifier: NCT00000374
• Recruitment Status: Completed
• First Posted: November 3, 1999
• Last Update Posted: January 13, 2012
• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH); The Zucker Hillside Hospital
• Information provided by (Responsible Party): Delbert Robinson, National Institute of Mental Health (NIMH)

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Olanzapine; Drug: Risperidone	Phase 4

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Preventing Morbidity in First-Episode Schizophrenia
• Study Start Date: September 1998
• Actual Primary Completion Date: May 2007
• Actual Study Completion Date: May 2007

Arms and Interventions

Intervention Details:

• Drug: Olanzapine
  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.
• Drug: Risperidone
  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.

Outcome Measures

Primary Outcome Measures :

1. Treatment response [ Time Frame: 8 consecutive weeks ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion Criteria:

• Prior treatment with antipsychotic medications.

Contacts and Locations

Locations

United States, New York

Bronx-Lebanon Hospital Center

Bronx, New York, United States, 10456

Hillside Hospital

Glen Oaks, New York, United States, 11004

Sponsors and Collaborators

Northwell Health

National Institute of Mental Health (NIMH)

The Zucker Hillside Hospital

Investigators

• Principal Investigator: Delbert Robinson, MD; The Zucker Hillside Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Delbert Robinson, Delbert Robinson, MD/Prinicipal Investigator, National Institute of Mental Health (NIMH)
• ClinicalTrials.gov Identifier: NCT00000374
• Other Study ID Numbers: R01MH060004-01 ( U.S. NIH Grant/Contract ); R01MH060004-01 ( U.S. NIH Grant/Contract ); DSIR 83-ATAP
• First Posted: November 3, 1999
• Last Update Posted: January 13, 2012
• Last Verified: January 2012

Keywords provided by Delbert Robinson, National Institute of Mental Health (NIMH):

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

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Olanzapine; Risperidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators