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RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
This study is ongoing, but not recruiting participants.
Study NCT00184106   Information provided by Norwegian University of Science and Technology
First Received: September 9, 2005   Last Updated: April 20, 2009   History of Changes

September 9, 2005
April 20, 2009
October 2004
 
  • The propotion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.
  • A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.
Same as current
Complete list of historical versions of study NCT00184106 on ClinicalTrials.gov Archive Site
Relapse rate during 6 and 12 months of follow up.
Same as current
 
RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
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

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.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Phobic Disorders
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
July 2009
 

Inclusion Criteria:

  1. Signed written informed consent obtained prior to entry in the study.
  2. Diagnosed with primary social phobia, generalized or specific (DSM-IV, APA, 1994).
  3. Symptoms present at least one year.
  4. Age between 18-65 years.

Exclusion Criteria:

  1. Known somatic diseases.
  2. Pregnant (*) or lactating women.
  3. Psychosis
  4. Acute suicidal symptoms
  5. Major depressive disorder
  6. Generalized Anxiety Disorder or PTSD
  7. Cluster A or cluster B personality disorder
  8. Substance abuse or dependence
  9. Body dysmorphic disorder.
  10. Not willing to accept random allocation.
  11. Patients who take some form of SSRI medications currently or during the last 6 months
  12. Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial or are taking herbal remedies that may be hazardous or inflict treatment response.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00184106
Professor Hans M Nordahl, Norwegian University of Science and Technology
SP/NTNU-2005
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Hans M Nordahl, Professor Norwegian University of Science and Technology, NTNU
Norwegian University of Science and Technology
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP