Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis
|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|
- Treatment response [ Time Frame: Measured at Weeks 12, 16, 32, 52 ] [ Designated as safety issue: No ]
- Patterns of change in weight and body mass index (BMI) [ Time Frame: Measured at Weeks 12, 16, 32, 52 ] [ Designated as safety issue: No ]
- Incidence rates of metabolic syndrome and new-onset diabetes [ Time Frame: Measured at Weeks 12, 16, 32, 52 ] [ Designated as safety issue: No ]
- Negative symptoms [ Time Frame: Measured at Weeks 12, 16, 32, 52 ] [ Designated as safety issue: No ]
- Cognition [ Time Frame: Measured at Weeks 12, 52 ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
- Adverse events other than metabolic [ Time Frame: Measured at Weeks 12, 16, 32, 52 ] [ Designated as safety issue: No ]
- Substance use [ Time Frame: Measured at Weeks 12, 16, 32, 52 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Participants will take 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
Participants will take 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
Participants will take 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:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320671
|United States, New York|
|The Zucker Hillside Hospital|
|Glen Oaks, New York, United States, 11004|
|Principal Investigator:||Delbert Robinson, MD||The North Shore-Long Island Jewish Health System|