|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Norwegian University of Science and Technology |
|---|---|
| Collaborator: |
St. Olavs Hospital |
| Information provided by (Responsible Party): | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00184106 |
Purpose
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 placebo.One hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. The first group (N=25) will be treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo and clinical management (N=25). 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Phobic Disorders |
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 86 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cognitive Therapy
Cognitive Therapy
|
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered opver 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
|
|
Active Comparator: Seroxat and SE
SSRI with Self exposure
|
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered opver 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
|
|
Active Comparator: Seroxat and Cognitive Therapy
Combination of Seroxat and Cognitive Therapy
|
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered opver 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
|
|
Placebo Comparator: Pill-Placebo
Pill Placebo
|
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered opver 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway | |
| Dept. of Psychology, NTNU | |
| Trondheim, Dragvoll, Norway, 7491 | |
| Principal Investigator: | Hans M Nordahl, Professor | Norwegian University of Science and Technology, NTNU |
More Information
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00184106 History of Changes |
| Other Study ID Numbers: | SP/NTNU-2005 |
| Study First Received: | September 9, 2005 |
| Last Updated: | August 23, 2011 |
| Health Authority: | Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services |
|
Phobic disorders Therapy, cognitive Paroxetin |
|
Phobic Disorders Anxiety Disorders Mental Disorders Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |