Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the effectiveness of various combinations of psychosocial therapy
      and risperidone treatment in improving work or school performance in people with
      first-episode schizophrenia.
    

Detailed description: 
      Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia
      often experience hallucinations, delusions, thought disorders, and movement disorders. These
      symptoms make it difficult to maintain a job, participate in school, and keep up self-care.
      Proper treatment of first-episode schizophrenia may increase the chances of controlling
      disease progression on a long-term basis. Antipsychotic medications, such as risperidone, and
      psychosocial treatments, such as cognitive enhancement training and health behavior training,
      are common, effective treatments for schizophrenia. This study will determine the
      effectiveness of various combinations of psychosocial therapy and risperidone treatment in
      improving work or school performance in people with first-episode schizophrenia.

      Participants in this open label study will be randomly assigned to receive one of the
      following four combinations of an antipsychotic medication and a psychosocial treatment:
      cognitive enhancement training plus oral risperidone; cognitive enhancement training plus
      long-acting injectable risperidone; health behavior training plus oral risperidone; or health
      behavior training plus long-acting injectable risperidone. Cognitive enhancement training
      will entail 2 hours per week of computer-assisted training targeted at improving attention,
      memory, and problem-solving skills. Additionally, participants will attend a weekly 1-hour
      group meeting to learn how to apply these skills to work and school situations. Health
      behavior training will involve 3 hours per week of relaxation training, nutrition education,
      and physical exercise to enhance wellness. Participants assigned to receive oral risperidone
      will receive their medication in pill form at the dosage determined to be optimal by the
      study psychiatrist. Participants assigned to receive injectable risperidone will be given one
      injection every 2 weeks. Dosages will start at 25 mg per injection and will be adjusted as
      needed.

      Treatment will continue for 1 year following dosage stabilization, which typically occurs 2
      to 3 months following study entry. For the first 6 months, participants assigned to receive
      health behavior training will attend study visits once a week and participants assigned to
      receive cognitive enhancement training will attend study visits once a week. For the final 6
      months, all participants will attend study visits twice weekly. At each visit, participants
      will receive their assigned psychosocial treatment; attend group therapy; meet with a case
      manager for counseling and assessment of symptoms, work functioning, and social functioning;
      and meet with a psychiatrist to monitor medication response. Additional cognitive and health
      behavior measures will be taken every 6 months to assess treatment effectiveness.
    

Intervention name(s): Cognitive remediation training (CT); Healthy behavior training (HBT); Risperidone, administered orally (Oral Ris); Risperidone, administered via injection (RLAI)
Intervention type(s): Behavioral; Behavioral; Drug; Drug
Intervention description(s): Cognitive remediation training includes computerized cognitive training plus learning skills group.; Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.; Oral risperidone at dosage judged optimal by treating psychiatrist; Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
Other intervention name(s): Risperdal; Risperdal Consta
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizoaffective Disorder, Depressed Type; Schizophreniform Disorder; First-Episode Schizophrenia; Supported Employment; Cognitive Remediation; Health Behavior Training; Antipsychotic Medication