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Completed

NCT Number: NCT00184106

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

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.

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Key information

Conditions

Phobic Disorders Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Psychology, NTNU

Trondheim, Dragvoll, 7491, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known somatic diseases.
  • Pregnant (*) or lactating women.
  • Psychosis
  • Acute suicidal symptoms
  • Major depressive disorder
  • Generalized Anxiety Disorder or PTSD
  • Cluster A or cluster B personality disorder
  • Substance abuse or dependence
  • Body dysmorphic disorder.
  • Not willing to accept random allocation.
  • Patients who take some form of SSRI medications currently or during the last 6 months
  • 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.

Treatment and study plan

Seroxat, Cognitive therapy, Seroxat+ cognitive therapy

Drug

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

Primary outcomes

  1. The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.

    Time frame: December 2010

  2. A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.

    Time frame: December 2010

Secondary outcomes

  1. Relapse rate during 6 and 12 months of follow up.

    Time frame: December 2010

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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