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RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
This study is currently recruiting participants.
Verified by Norwegian University of Science and Technology, January 2007
Sponsors and Collaborators: Norwegian University of Science and Technology
St. Olavs Hospital
Information provided by: 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

MedlinePlus related topics: Phobias
Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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%.

Secondary Outcome Measures:
  • Relapse rate during 6 and 12 months of follow up.

Estimated Enrollment: 100
Study Start Date: October 2004
Estimated Study Completion Date: July 2009
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184106

Contacts
Contact: Hans M Nordahl, PhD 73 59 82 92 hans.nordahl@svt.ntnu.no

Locations
Norway, Dragvoll
Dept. of Psychology, NTNU Recruiting
Trondheim, Dragvoll, Norway, 7491
Contact: Hans M Nordahl, Professor     + 47 72598292     hans.nordahl@svt.ntnu.no    
Principal Investigator: Hans M Nordahl, Ph.D            
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Hans M Nordahl, Professor Norwegian University of Science and Technology, NTNU
  More Information

Study ID Numbers: SP/NTNU-2005
Study First Received: September 9, 2005
Last Updated: January 18, 2007
ClinicalTrials.gov Identifier: NCT00184106  
Health Authority: Norway: Norwegian Medicines Agency;   Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Phobic disorders
Therapy, cognitive
Paroxetin

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Phobic Disorders
Paroxetine
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Serotonin Uptake Inhibitors
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009