Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229645
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2005-09-28
Brief Title:
A Double Blind Randomized Placebo Controlled Study of the Efficacy Safety and of Quetiapine Fumarate Seroquel as Potentiation SSRIs and SNRIs Treatment in Major Depression With Anxiety
Sponsor:
Dr Alexander McIntyre Inc
Organization:
Dr Alexander McIntyre Inc
Study Overview
Official Title:
A Double Blind Randomized Placebo Controlled Study of the Efficacy Safety and Tolerability of Immediate-Release Formulation of Quetiapine Fumarate as Potentiation of Selective Serotonin Reuptake Inhibitors and Serotonin Norepinephrine Reuptake Inhibitors Treatment in Major Depression With Comorbid Anxiety Symptoms
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Major depression occurs with generalized anxiety disorder and panic disorder in up to 60 of psychiatric and primary care patients1 An estimated 85 of adults with depression experience significant symptoms of anxiety and 58 have a diagnosable anxiety disorder during their lifetime2 Numerous studies have shown that symptoms of anxiety are frequent in patients with major depressive disorder and the presence of anxiety symptoms is associated with a more severe and chronic course34 This comorbidity has been associated with a greater severity of depression poorer psychosocial functioning poorer treatment response and higher risk for suicide
The data suggests that novel antipsychotics have antidepressant and anxiolytic effects This study will explore the impact of this effect in patients with major depression and comorbid anxiety symptoms
This study offers the possibility of systematically reviewing the role of quetiapine in depression with anxiety If the combination of an SSRI or SNRI and quetiapine proves to effective it could offer a viable alternative to widespread benzodiazepine use
The data suggests that novel antipsychotics have antidepressant and anxiolytic effects This study will explore the impact of this effect in patients with major depression and comorbid anxiety symptoms
This study offers the possibility of systematically reviewing the role of quetiapine in depression with anxiety If the combination of an SSRI or SNRI and quetiapine proves to effective it could offer a viable alternative to widespread benzodiazepine use
Detailed Description:
This is a double blind study where patients will be involved and be under treatment for a period of 8 weeks The initial evaluation will include rating scales measuring depression anxiety severity of illness overall functioning pregnancy test and clinical evaluations Patients being treated with a SSRI or SNRI for at least 6 weeks at therapeutic doses see table 1 who still have a HAM-D score of 18 or more will be randomly assigned to treatment either with Quetiapine or Placebo Patients in the active group will be titrated on a fixed schedule of 50 mg at night for 7 days 100 mg at night for 7 days then 200 mg at night for 7 days After this the dose will be titrated upwards to a maximum of 600mg at night at the discretion of the investigator using patient tolerance and response as guidelines over the duration of the trial 200mg is in the range of the average dose in large trials of naturalistic clinical use of quetiapine and is actually much slower than the titration schedule on the package label Patients that can not tolerate 200mgday will be withdrawn from the study Patients should have tried a minimum of 400mg day before being withdrawn because of lack of efficacy This dose will remain steady until week 8 Rating scales will be repeated every week during the first 2 weeks and every 2 weeks up to the end of the study at week 8
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