Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184106
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2005-09-09
Brief Title:
RCT of Cognitive Therapy Paroxetine Combined CT and Paroxetine and Placebo
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
A Randomised Triple Blind Placebo-controlled Trial Comparing the Effects of Cognitive Therapy Paroxetine and Both Cognitive Therapy and Paroxetine in the Treatment of Patients With Primary Social Phobia
Status:
COMPLETED
Status Verified Date:
2018-08
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:
We aim to 1 evaluate the effectiveness of cognitive therapy and paroxetine and their combination 2 investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive behavioural and physiological mechanisms in the patients response to CT to paroxetine and placeboOne hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions The first group N25 will be treated with CT alone the second group N25 with CT plus paroxetine the third group N25 with paroxetine and clinical management TAU the fourth group will receive placebo and clinical management N25 All patients will have 12 weeks of treatment in the acute phase which includes 12 sessions of individual treatment for the two first groups The 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase The 4th group will have placebo for 24 weeks and clinical management The patients will be assessed at pre-treatment at 12 weeks and at the end of treatment of the acute phase 12 weeks and by the end of maintenance phase 24 weeks Follow-up will be at 6 and 12 months
Measures are based on all three main sources self-report inventories clinical assessments by independent raters and psycho-physiological assessments
Measures are based on all three main sources self-report inventories clinical assessments by independent raters and psycho-physiological assessments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None