Cognition, Functioning and Quality of Life
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      People affected by schizophrenia often experience poor concentration, lapses in memory and
      difficulty with completing tasks; and this set of problems are known as neuro-cognitive
      deficits. Traditional medications used in the treatment of schizophrenia have not been
      particularly useful in improving these problems, while the recently introduced medications
      are expected to be superior in this respect. The proposed research study is designed to
      assess the effect of two of the new medications (Zyprexa and Seroquel) in improving the
      neurocognitive deficits associated with schizophrenia.
    

Detailed description: 
      Schizophrenia is a chronic, debilitating psychiatric disorder with complex clinical
      presentation, partially responsiveness to treatment and varied outcomes. Though modern
      anti-psychotic drugs have been used to treat the illness for the past 50 years, it has been
      consistently observed that a significant proportion of people diagnosed with schizophrenia do
      not respond adequately to these medications. Even among those people who show symptomatic
      improvement, the benefit does not translate into improved functioning in real life setting.

      Research in the past 10 years revealed two significant findings: 1) it is now known that a
      proportion of people with schizophrenia have neurocognitive deficits as part of their
      clinical profile. Neuro-cognitive deficits refer to impairments in attention, concentration,
      memory, use of language, decision making and subtle aspects of judgment. 2) Traditional
      antipsychotic drugs have not been useful in improving neurocognitive deficits, while claims
      have been made that novel antipsychotic drugs (Quetiapine, Olanzapine and Risperidone) may
      have some beneficial effects in improving the neurocognitive deficits associated with
      schizophrenia. In an earlier investigation, we have noticed that Quetiapine produced
      clinically significant improvement in neurocognitive deficits compared to other antipsychotic
      drugs; and there have been two additional reports confirming this distinctive advantage of
      Quetiapine.

      Based on these preliminary results, the present study is designed to address the following
      questions. 1) To examine whether the neurocognitive deficits associated with schizophrenia
      have an impact on the community functioning and quality of life of individuals affected by
      this illness, and 2) whether Quetiapine (Seroquel) is significantly more effective than
      Olanzapine (Zyprexa) in improving neurocognitive deficits, community functioning and quality
      of life.

      The study sample will include a total of 120 patients with the diagnosis of schizophrenia or
      schizoaffective disorder, who will require antipsychotic drug treatment. The sample size
      calculation is based on the expected differences between the two compared medications, in
      terms of their ability to improve the neurocognitive cluster score on PANSS (Positive and
      negative symptoms scale) detected in our earlier study.The study is designed as a prospective
      double-blind, randomized controlled trial, using Quetiapine and Olanzapine as drugs for
      comparison. Eligible participants will undergo a baseline clinical and neurocognitive
      evaluation and randomly assigned to receive either Quetiapine or Olanzapine treatment. Both
      patients and controls are blinded to the nature of the medication being prescribed. However,
      the clinicians will have the flexibility to increase the dose as clinically appropriate. The
      goal is to achieve symptom stability and monitor the progress in community functioning, and
      changes in perceived quality of life. The participants will continue with the medication at
      least for a period of one year, and the outcome evaluations will be performed at 1, 3, 6, 9
      and 12 month points. These include re-assessment of clinical symptoms and neurocognitive
      deficits and community functioning, using appropriate measurement tools.
    

Intervention name(s): Olanzapine & Quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive deficits; Psychosocial functioning; Quality of Life