Cognition, Functioning and Quality of Life

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182442
First received: September 14, 2005
Last updated: October 10, 2006
Last verified: March 2005
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Olanzapine & Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One-Year Multi-Centre Randomized, Double Blind, Controlled Effectiveness Study of Quetiapine and Olanzapine, Comparing Their Relative Potential in Improving Neuro-Cognitive Deficits, Functional Outcomes and Quality of Life in Schizophrenia

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Primary outcome measures include changes in neurocognitive test scores, changes in measures of community functioning and quality of life.

Secondary Outcome Measures:
  • Secondary outcomes include changes in treatment adherence, subjective satisfaction with antipsychotic drug therapy, clinical symptoms and side effects.

Estimated Enrollment: 80
Study Start Date: October 2003
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia confirmed by administering SCID and,
  • Subjects consecutively referred for optimizing antipsychotic drug therapy, i.e. a change of medication from conventional medications or Risperidone is indicated due to lack of efficacy, side-effects or poor subjective tolerability.
  • Competent to provide an informed consent.

Exclusion Criteria:

  • Substance dependence, mental retardation, head injury or other primary neurological disorders.
  • Imminent risk due to suicidal or aggressive behavior (a score of five or more on the hostility item on the PANSS).
  • A pattern of social instability, which could hamper long-term follow-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182442

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
AstraZeneca
Investigators
Principal Investigator: Lakshmi P Voruganti, MD McMaster University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182442     History of Changes
Other Study ID Numbers: 02-2179
Study First Received: September 14, 2005
Last Updated: October 10, 2006
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Cognitive deficits
Psychosocial functioning
Quality of Life

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on August 28, 2014