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

NCT00184106 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2018-08-27

No results posted yet for this study

Summary

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.

Conditions

  • Phobic Disorders

Interventions

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

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Hans M Nordahl, Professor · Norwegian University of Science and Technology, NTNU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00184106 on ClinicalTrials.gov