Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

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 complete blood count (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 (Selective serotonin reuptake inhibitor)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
    

Intervention name(s): Aripiprazole; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Abilify; Risperdal
Intervention MeSH terms: Risperidone; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: First-episode; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder Not Otherwise Specified NOS; Aripiprazole; Clozapine; Risperidone