RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo

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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Cognitive Therapy
  • Cognitive Therapy
• Active Comparator: Seroxat and SE
  • SSRI with Self exposure
• Active Comparator: Seroxat and Cognitive Therapy
  • Combination of Seroxat and Cognitive Therapy
• Placebo Comparator: Pill-Placebo
  • Pill Placebo

Primary Measures

• The propotion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.
  • Time Frame: December 2010
    Safety Issue?: No
• A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.
  • Time Frame: December 2010
    Safety Issue?: No

Secondary Measures

• Relapse rate during 6 and 12 months of follow up.
  • Time Frame: December 2010
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Norwegian University of Science and Technology Other

Overall Clinical Trial Officials and Contacts

Hans M Nordahl, Professor Principal Investigator Norwegian University of Science and Technology, NTNU  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00184106

Study ID Number: SP/NTNU-2005

ClinicalTrials.gov Identifier: NCT00184106

Health Authority: Norway: Norwegian Medicines Agency