Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182442
Status:
COMPLETED
Last Update Posted:
2006-10-11
First Post:
2005-09-14
Brief Title:
Cognition Functioning and Quality of Life
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studyThe 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
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 studyThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None