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

August 23, 2018 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Therapy
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered over 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
Other Names:
  • Paroxetine
Active Comparator: Seroxat and SE
SSRI with Self exposure
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered over 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
Other Names:
  • Paroxetine
Active Comparator: Seroxat and Cognitive Therapy
Combination of Seroxat and Cognitive Therapy
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered over 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
Other Names:
  • Paroxetine
Placebo Comparator: Pill-Placebo
Pill Placebo
Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
Seroxat was administered over 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
Other Names:
  • Paroxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.
Time Frame: December 2010
December 2010
A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.
Time Frame: December 2010
December 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Relapse rate during 6 and 12 months of follow up.
Time Frame: December 2010
December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2004

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP/NTNU-2005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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