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

Norwegian University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Phobic Disorders

Treatments: Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00184106

SP/NTNU-2005

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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86 participants in 4 patient groups, including a placebo group

Cognitive Therapy

Active Comparator group

Description:

Cognitive Therapy

Treatment:

Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy

Seroxat and SE

Active Comparator group

Description:

SSRI with Self exposure

Treatment:

Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy

Seroxat and Cognitive Therapy

Active Comparator group

Description:

Combination of Seroxat and Cognitive Therapy

Treatment:

Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy

Pill-Placebo

Placebo Comparator group

Description:

Pill Placebo

Treatment:

Drug: Seroxat, Cognitive therapy, Seroxat+ cognitive therapy