Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia
Condition: Schizophrenia (Recent-onset)
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting
      injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode
      schizophrenia.
    

Detailed description: 
      Schizophrenia is a severely disabling brain disorder. People with schizophrenia often
      experience hallucinations, delusions, thought disorders, and movement disorders. Proper
      treatment of first-episode schizophrenia may increase the chances of controlling disease
      progression on a long-term basis. People experiencing their first episode of schizophrenia
      are more responsive to treatment than those with chronic schizophrenia, but are also more
      susceptible to adverse treatment side effects. Atypical antipsychotic medications have been
      shown to produce fewer extrapyramidal side effects than older "typical" antipsychotics. Oral
      risperidone is an atypical antipsychotic medication that is very commonly used to control the
      symptoms of schizophrenia. Adherence to prescribed oral medication continues to be a major
      clinical issue. This study will determine the effectiveness of oral risperidone versus a
      long-acting injectible alternative, paliperidone palmitate, in treating people with
      first-episode schizophrenia. Impact on clinical symptoms and cognitive functioning will be
      examined.

      Participants in this open label study will be randomly assigned to receive either orally
      administered risperidone or long-acting paliperidone palmitate administered via injection.
      Participants assigned to oral risperidone will receive medication in doses that are
      determined to be optimal by the study psychiatrist. Participants assigned to long-acting
      risperidone will receive an injection of paliperidone palmitate once every 4 weeks. Dosages
      will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to
      achieve outpatient oral risperidone dosage stabilization, the randomized medication
      conditions will begin and participants will be monitored for 1 year. Study visits will occur
      once weekly throughout the study. They will include psychiatrist monitoring of medication
      response and side effects; group therapy meetings focused on everyday living skills; family
      education about schizophrenia; and individual meetings with a case manager for counseling and
      evaluations of schizophrenia symptoms, work recovery, and social functioning.
    

Intervention name(s): paliperidone palmitate; risperidone
Intervention type(s): Drug; Drug
Intervention description(s): long-acting injectable; oral
Other intervention name(s): Invega Sustenna; Risperdal
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First-episode Schizophrenia; Schizoaffective Disorder, Depressed Type (recent-onset); Schizophreniform Disorder; oral risperidone; long-acting injectable paliperidone palmitate; functional outcome