Cognition, Functioning and Quality of Life
|First Received Date ICMJE||September 14, 2005|
|Last Updated Date||October 10, 2006|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Primary outcome measures include changes in neurocognitive test scores, changes in measures of community functioning and quality of life.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00182442 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Secondary outcomes include changes in treatment adherence, subjective satisfaction with antipsychotic drug therapy, clinical symptoms and side effects.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Cognition, Functioning and Quality of Life|
|Official Title ICMJE||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|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Olanzapine & Quetiapine|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00182442|
|Other Study ID Numbers ICMJE||02-2179|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hamilton Health Sciences Corporation|
|Information Provided By||McMaster University|
|Verification Date||March 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP