Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113295
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2005-06-07
Brief Title:
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Status:
COMPLETED
Status Verified Date:
2014-03
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:
The purpose of this study is to examine the safety and efficacy of quetiapine for generalized anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR
Detailed Description:
Generalized anxiety disorder GAD is a relatively common condition affecting 5 of the population with a typically chronic course and associated with significant psychosocial impairment and decreased quality of life Schweizer 1995 Although a number of therapeutic agents demonstrate some efficacy in the treatment of generalized anxiety disorder only a minority of anxious patients experience remission with initial treatment
The purpose of this study is to examine the efficacy of one strategy the addition of quetiapine for the treatment of patients with GAD who remain refractory despite an adequate treatment trial with a selective serotonin reuptake inhibitor SSRI This is an investigator-initiated augmentation study of an already approved drug for a different indication Quetiapine is a novel antipsychotic agent with potent effects at the serotonergic as well as dopaminergic receptor and a more favorable side effect profile than standard neuroleptics including a low potential to cause extrapyramidal symptoms
This is a two phase 18-week research study in which participants who remain symptomatic at the end of one phase 10 weeks enter into the next phase In phase I all participants receive paroxetine CR Paxil CR for 10 weeks Participants who continue to have anxiety symptoms will enter the 8-week Phase II in which they continue taking Paxil CR and they will also be randomly assigned by chance like a flip of a coin to receive quetiapine Seroquel or placebo contains no active medication
The purpose of this study is to examine the efficacy of one strategy the addition of quetiapine for the treatment of patients with GAD who remain refractory despite an adequate treatment trial with a selective serotonin reuptake inhibitor SSRI This is an investigator-initiated augmentation study of an already approved drug for a different indication Quetiapine is a novel antipsychotic agent with potent effects at the serotonergic as well as dopaminergic receptor and a more favorable side effect profile than standard neuroleptics including a low potential to cause extrapyramidal symptoms
This is a two phase 18-week research study in which participants who remain symptomatic at the end of one phase 10 weeks enter into the next phase In phase I all participants receive paroxetine CR Paxil CR for 10 weeks Participants who continue to have anxiety symptoms will enter the 8-week Phase II in which they continue taking Paxil CR and they will also be randomly assigned by chance like a flip of a coin to receive quetiapine Seroquel or placebo contains no active medication
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