|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | North Shore Long Island Jewish Health System |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by (Responsible Party): | North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT00320671 |
Purpose
This 52 week long study evaluates the effectiveness of aripiprazole versus risperidone in treating people with first-episode schizophrenia. Patients who do not improve with these medications receive clozapine as their third medication trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Aripiprazole Drug: Risperidone Drug: Clozapine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Preventing Morbidity in First Episode Schizophrenia, Part II |
| Estimated Enrollment: | 242 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will take aripiprazole
|
Drug: Aripiprazole
The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
Other Name: Abilify
|
|
Experimental: 2
Participants will take risperidone
|
Drug: Risperidone
The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
Other Name: Risperdal
|
|
Experimental: 3
Participants will take Clozapine
|
Drug: Clozapine
The dosage for clozapine will be 12.5 mg per day on day 1; 25 mg per day on days 2 and 3; 50 mg per day on days 4 and 5; 75 mg per day on days 6 and 7; 100 mg per day on days 8 and 9, and increments of 50 mg per day every 2 days until treatment response, dose-related side effects, or a maximum dose of 600 mg/day. Safety monitoring for clozapine-treated subjects will follow the established procedures for multi-episode patients (e.g. weekly CBC monitoring). Subjects who participate in the clozapine trial will be seen for research assessments weekly for 4 weeks, then every two weeks until study end
Other Name: Clozaril
|
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Medications are available to alleviate the symptoms of schizophrenia, but many cause undesirable side effects. For example, two early second generation antipsychotics, olanzapine and risperidone, have been shown to be effective in treating schizophrenia symptoms, but cause rapid, substantial weight gain. There is a lower risk of such side effects with newer second generation antipsychotics, such as aripiprazole. Little is known, however, about the effectiveness of these newer medications in treating people with first-episode schizophrenia. This study will evaluate the effectiveness of aripiprazole versus risperidone for the treatment of first-episode schizophrenia.
Participants in this double-blind study will be randomly assigned to receive either aripiprazole or risperidone for 12 weeks. Subjects who do not meet response criteria will be continued on their initial blinded antipsychotic for an additional 4 weeks for a total length of 16 weeks of treatment. Subjects who meet response criteria by week 16 will continue on their successful blinded medication for their remaining time in study. Patients who do not respond will be treated with the other medication (aripiprazole or risperidone) that they did not receive during the first 16 weeks of the study. The second antipsychotic trial will last 16 weeks. Patients who respond during the switch phase will be continued on their successful medication during their remaining time in the study. Patients who do not respond to the second medication trial will then be treated with open-label clozapine for 20 weeks. Safety monitoring for clozapine-treated subjects will follow the established procedures for multi-episode patients (e.g . weekly CBC monitoring). The total length of patient participation is 52 weeks.
During the longitudinal follow-up phase, subjects may be prescribed open-label sodium valproate for manic symptoms and open-label sertraline for symptoms of depression or anxiety empirically responsive to SSRI treatment. Additionally, all participants will take part in a Healthy Lifestyles program aimed at preventing weight gain. The Healthy Lifestyles program will provide psycho-education, supportive psychotherapy, and medication adherence counseling. At each visit, treatment and metabolic outcomes will be assessed. Participants will meet with both a psychiatrist, who will evaluate progress and medication dosage, and a social worker, who will administer the Healthy Lifestyles Program. Upon completion of the study, participants will receive follow-up care from clinical staff members who were not part of the research team.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00000374
Eligibility| Ages Eligible for Study: | 15 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joanne McCormack, LMSW | 718-470-8446 | JmcCorma@lij.edu |
| Contact: Delbert Robinson, MD | 718-470-8195 | robinson@lij.edu |
| United States, New Jersey | |
| East Orange General Hospital | Recruiting |
| East Orange, New Jersey, United States, 07018 | |
| Contact: Chitra Malur, MD 973-266-2930 Malurc@evh.org | |
| United States, New York | |
| Brookdale University Hospital and Medical Center | Recruiting |
| Brooklyn, New York, United States, 11212 | |
| Contact: Pierre Jean-Noel, MD 718-240-5496 Pjeannoel@brookdale.edu | |
| Principal Investigator: Seth Vivek, M.D. | |
| The Zucker Hillside Hospital | Recruiting |
| Glen Oaks, New York, United States, 11004 | |
| Contact: Joanne McCormack, MSW 718-470-8446 JmcCorma@lij.edu | |
| Contact: Delbert Robinson, MD 718-470-8195 robinson@lij.edu | |
| Principal Investigator: Delbert Robinson, MD | |
| Sub-Investigator: Serge Sevy, MD | |
| Jamaica Hospital | Recruiting |
| Jamaica, New York, United States, 11418 | |
| Contact: Tom Pawelzik, L Psic 718-206-7318 tpawelzi@jhmc.org | |
| Principal Investigator: Seeth Vivek, MD | |
| North Shore University Hospital | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Delbert Robinson, MD 718-470-8195 robinson@lij.edu | |
| Principal Investigator: Delbert Robinson, MD | |
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Patrick Smith 210-562-5457 smithpm@uthscsa.edu | |
| Principal Investigator: Alexander Miller, MD | |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Contact: Nicole McKenzie, M.Sc. (403) 210-6026 mckenzin@ucalgary.ca | |
| Contact: Laina McAusland, RN 403-210-6497 lbsorens@ucalgary.ca | |
| Principal Investigator: Jean Addington, PhD. | |
| Principal Investigator: | Delbert Robinson, MD | The North Shore-Long Island Jewish Health System |
More Information
| Responsible Party: | North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT00320671 History of Changes |
| Other Study ID Numbers: | R01 MH060004-02, R01MH060004-02, DSIR 83-ATAP |
| Study First Received: | May 1, 2006 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Federal Government |
|
First-episode Schizoaffective Disorder Schizophreniform Disorder Psychotic Disorder NOS |
Aripiprazole Clozapine Risperidone |
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Clozapine Risperidone Aripiprazole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents Dopamine Antagonists Dopamine Agents |
