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

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184106
First received: September 9, 2005
Last updated: August 23, 2011
Last verified: August 2011
  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 4

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

Resource links provided by NLM:


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. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • A patient is classified as responder if the decrease on FNE is equivalent with or above 40%. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse rate during 6 and 12 months of follow up. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Norway
Dept. of Psychology, NTNU
Trondheim, Dragvoll, Norway, 7491
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

No publications provided

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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 21, 2014