Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00320671
First received: May 1, 2006
Last updated: May 29, 2014
Last verified: May 2014
  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 4

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

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 242
Study Start Date: December 2005
Estimated Study Completion Date: October 2015
Primary Completion Date: February 2014 (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

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Current DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or similar psychotic disorder not otherwise specified, as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P)
  • History of previous antipsychotic medication treatment for a duration of 2 weeks or less
  • Current positive symptoms rated 4 (moderate) or more on one or more of the following Brief Psychiatric Rating Scale (BPRS-A) items: conceptual disorganization; grandiosity; hallucinatory behavior; or unusual thought content
  • Agrees to use an effective form of contraception

Exclusion Criteria:

  • Any serious neurological or endocrine disorder, or any medical condition or treatment known to affect the brain
  • Any current medical condition that requires treatment with a medication with psychotropic effects
  • At significant risk for suicidal or homicidal behavior
  • Cognitive or language limitations, or any other factor that would interfere with a participant's ability to provide informed consent or safely participate in study procedures
  • Diagnosis of diabetes, defined as a fasting plasma glucose level of at least 126 mg/dL, or metabolic syndrome, defined as three or more of the following: high blood pressure (greater than 135/85 mmHg); truncal obesity (having a waist circumference greater than 40 inches for men and greater than 35 inches for women); elevated fasting glucose (greater than 110 mg/dL); low HDL-cholesterol (less than 40 mg/dL for men and less than 50 mg/dL for women); or elevated triglycerides (defined as greater than 150 mg/dL)
  • Requires treatment with an antidepressant or mood stabilizing medication
  • Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features
  • Any medical conditions that would make treatment with risperidone or aripiprazole medically inadvisable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320671

Locations
United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Delbert Robinson, MD The North Shore-Long Island Jewish Health System
  More Information

No publications provided

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: May 29, 2014
Health Authority: United States: Federal Government

Keywords provided by North Shore Long Island Jewish Health System:
First-episode
Schizoaffective Disorder
Schizophreniform Disorder
Psychotic Disorder NOS
Aripiprazole
Clozapine
Risperidone

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 22, 2014