Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517387
Status:
COMPLETED
Last Update Posted:
2010-11-16
First Post:
2007-08-14
Brief Title:
The Effects of Quetiapine XR on Cognition Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The Effects of Quetiapine XR on Cognition Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression
Status:
COMPLETED
Status Verified Date:
2010-11
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:
Recently published work has examined the effects of atypical antipsychotics in SSRI-treatment resistant patients In these studies patients with unipolar depression who were treated with SSRIs but not responsive to treatment after 4 or more weeks were supplemented with an atypical The atypical antipsychotics were found to diminish depression symptoms as well as benefit sleep quality
We propose a similar study with Quetiapine XR focusing on thinking processes mood and anxiety Patients with depression who are SSRI treatment resistant will be treated with Quetiapine Cognition will be evaluated in the UBC Mood Disorders Clinic two times first before Quetiapine addition then after 8 weeks Depression symptoms and other measurements will be done at the 9 time points before Quetiapine and each week after treatment has begun
The primary purpose of this study is to evaluate the superiority of Quetiapine XR compared to placebo as augmentation therapy in treatment of anxiety and depressive symptoms in SSRI-nonresponsive unipolar patients Secondarily we would like to evaluate the safety and tolerability of quetiapine as augmentation therapy in SSRI-nonresponsive unipolar patients
We propose a similar study with Quetiapine XR focusing on thinking processes mood and anxiety Patients with depression who are SSRI treatment resistant will be treated with Quetiapine Cognition will be evaluated in the UBC Mood Disorders Clinic two times first before Quetiapine addition then after 8 weeks Depression symptoms and other measurements will be done at the 9 time points before Quetiapine and each week after treatment has begun
The primary purpose of this study is to evaluate the superiority of Quetiapine XR compared to placebo as augmentation therapy in treatment of anxiety and depressive symptoms in SSRI-nonresponsive unipolar patients Secondarily we would like to evaluate the safety and tolerability of quetiapine as augmentation therapy in SSRI-nonresponsive unipolar patients
Detailed Description:
This is a double-blind placebo-controlled study in which patients will receive treatment of Quetiapine XR for 8 weeks All patients will receive Quetiapine XR at an initial dose of 50mgday to be increased incrementally dose of 50mgday 2 and 150mgday 3 to achieve a target dose of 300 mgday by day 4 Tablets will be self-administered early each night Patients results will be compared to their own baseline measurements in a double-blind fashion
Recruited patients will be evaluated at nine time points a baseline prior to treatment t -7 days an assessment one week after treatment has begun t 7 days two weeks after t 14 days three weeks after t 21 days four weeks after t 28 days five weeks after t 35 days six weeks after t 42 days seven weeks after t 49 days and after 8 weeks of treatment t 56 days Evaluation of cognition mood and anxiety will be done blind to which time point is being measured
Basic blood work fasting blood glucose lipid screen including triglycerides urea and electrolytes cytokines and neuroimmune markers will performed on each patient both at baseline t -7 days and at t 56 days At 4 weeks blood sample will be taken for fasting plasma glucose HbA1c and transaminases At baseline -7 days and completion 56 days a battery of neurocognitive-impairment tests see Appendix A will be administered In addition the Hamilton Rating Scale for Depression 21-ITEM HAM-D GRID Montgomery -Asberg Depression Rating Scale MADRS Hamilton Ratings Scale for Anxiety HAM-A the UKU Side Effect Rating Scale and the Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q will also be assessed by the research team
Recruited patients will be evaluated at nine time points a baseline prior to treatment t -7 days an assessment one week after treatment has begun t 7 days two weeks after t 14 days three weeks after t 21 days four weeks after t 28 days five weeks after t 35 days six weeks after t 42 days seven weeks after t 49 days and after 8 weeks of treatment t 56 days Evaluation of cognition mood and anxiety will be done blind to which time point is being measured
Basic blood work fasting blood glucose lipid screen including triglycerides urea and electrolytes cytokines and neuroimmune markers will performed on each patient both at baseline t -7 days and at t 56 days At 4 weeks blood sample will be taken for fasting plasma glucose HbA1c and transaminases At baseline -7 days and completion 56 days a battery of neurocognitive-impairment tests see Appendix A will be administered In addition the Hamilton Rating Scale for Depression 21-ITEM HAM-D GRID Montgomery -Asberg Depression Rating Scale MADRS Hamilton Ratings Scale for Anxiety HAM-A the UKU Side Effect Rating Scale and the Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q will also be assessed by the research team
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