Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the safety and effectiveness of three different antipsychotic
      medications, as well as the use of other medications to limit treatment side effects, in
      adults with schizophrenia.
    

Detailed description: 
      Schizophrenia is a chronic brain disease affecting approximately 1% of Americans.
      Antipsychotic medications can treat some of the most severe symptoms of schizophrenia, but
      they are not a cure, are often taken for long periods of time, and can have severe side
      effects. Other, secondary medications can provide relief from some of the most common severe
      side effects. This study will compare the safety and effectiveness of three different
      antipsychotic medications, as well as the use of additional medications to limit treatment
      side effects, in adults with schizophrenia.

      Participation in this study will last 28 to 30 weeks and include 11 visits to a study clinic.
      Each visit will last 2 to 3 hours. The first 2 visits will include screening and baseline
      measurements. The screening visit will take place at study entry, and the baseline visit will
      take place 3 to 14 days later. Study visits will then occur 1, 2, and 4 weeks after the
      baseline visit, followed by monthly visits.

      At the baseline visit participants will be randomly assigned to receive olanzapine,
      perphenazine, or aripiprazole for 28 weeks. Dosage for all three antipsychotic medications
      will start at low levels and be increased to full strength over 2 weeks. If participants are
      taking another antipsychotic when they enter the study, this 2-week period will also be used
      to slowly reduce and then end treatment with the non-study antipsychotic. Side effects to all
      three antipsychotics will be monitored, and, depending on the side effect, one of three
      different medications will be added to the treatment regimen. If increased cholesterol levels
      are experienced with any antipsychotic, simvastatin will be added; if weight gain is
      experienced, metformin will be added; if involuntary movements, inner restlessness, or muscle
      stiffness are experienced, benztropine will be added. Because of already known side effects,
      participants assigned to olanzapine or perphenazine will automatically add metformin or
      benztropine, respectively, to their regimens.

      Starting on the third study visit, participants will also undergo a behavioral treatment
      aimed at reducing cardiovascular risk factors. This behavioral treatment will involve nine
      20-minute sessions, with phone calls being made to participants between sessions.

      During each study visit, assessments will be made of schizophrenia symptoms, side effects,
      adherence to medication regimen, vital signs, waist circumference, and weight. Participants
      will also complete a questionnaire on use of health care services and undergo instructions on
      exercise and eating right. On visits 1, 5, 7, and 11, blood will be drawn for standard lab
      tests. Additional measures at the screening visit will include questions about medical and
      psychiatric history, a urine test for drugs, and a questionnaire about physical and social
      activities.
    

Intervention name(s): Olanzapine; Perphenazine; Aripiprazole; Metformin; Simvastatin; Benztropine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Daily tablets of 10 to 30 mg; Daily tablets of 8 to 24 mg; Daily tablets of 10 to 30 mg; Daily tablets of 850 to 2550 mg; Daily tablets of 20 to 40 mg; Daily tablets of 1 to 2 mg
Other intervention name(s): Zyprexa; Trilafon; Abilify; Glucophage; Zocor; Cogentin
Intervention MeSH terms: Metformin; Benztropine; Olanzapine; Aripiprazole; Perphenazine; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizoaffective Disorder