Treatment of Panic Disorder: Long Term Strategies

Panic Disorder Clinical Trial

Official title:

Treatment of Panic Disorder: Long Term Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000368
• Other study ID #: R01MH045964
• Secondary ID: R01MH045964R01MH
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: March 17, 2014
• Start date: February 1999
• Est. completion date: July 2004

Study information

• Verified date: March 2014
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone.

It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first.

All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years.

An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.

Description:

To determine if maintenance CBT produces a more sustained improvement among patients with panic disorder (PD) who respond to an initial course of cognitive behavior therapy (CBT) alone. For those who do not respond sufficiently to CBT alone, to determine if the addition of pharmacotherapy is acceptable and if this improves response among those inadequate responders to CBT alone.

This multicenter study builds upon the findings of a prior study comparing imipramine, placebo, CBT, and their combination in the treatment of PD patients with no more than mild agoraphobia. That study found response rates were as high with CBT or imipramine alone as with their combination. Given the added cost of combined treatments, it therefore seems reasonable to begin with monotherapy. Further, following general principles of medical practice, it would be reasonable to initiate treatment with the less invasive cognitive behavioral intervention. It is then important to learn what should be done following initial treatment.

All patients initially receive CBT alone. Patients are then randomized into 1 of 2 post-acute studies, depending on response status. Responders are randomized to a maintenance study comparing no maintenance with 9 months of continued CBT. Nonresponders are randomized to a study comparing paroxetine with continued CBT. The following outcomes will be examined: the necessity of maintenance therapy in maintaining response; the ability of adjunct pharmacotherapy to improve the response of patients who did not respond to CBT alone; possible predictors of response and relapse; and possible mediators of response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary diagnosis of Panic disorder with or without Agoraphobia (all levels of agoraphobia are included).

Exclusion Criteria:

• current substance abuse or dependence,

• current active suicidal potential;

• any history of psychosis, bipolar disorder (I or II) or cyclothymia;

• pending application or existing medical disability claim;

• significant cognitive impairment,

• current uncontrolled general medical illness requiring intervention,

• psychotherapy directed at anxiety or panic which will not be discontinued by the first treatment visit, and daily use of 2mg of Xanax or equivalent.

Exclusion criteria for paroxetine study:

• hypersensitivity to Selective Serotonin Reuptake Inhibitors (SSRI),

• pregnancy, lactation, or planned pregnancy during the course of the study,

• contemporaneous medication that may interfere or interact with paroxetine,

• prior treatment with therapeutic doses of paroxetine (40mg/d for 1 mo),

• concurrent treatment with antidepressants.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agoraphobia
• Disease
• Panic Disorder

Intervention

Behavioral:
• Cognitive behavior therapy

Drug:
• Paroxetine or other medication - algorithm used

Locations

Country	Name	City	State
United States	Boston University, Department of Psychology, Center for Anxiety and Related Disorders	Boston	Massachusetts
United States	Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic	New Haven	Connecticut
United States	Hillside Hospital Phobia Clinic	New York	New York
United States	University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barlow DH, Gorman JM, Shear MK, Woods SW. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. JAMA. 2000 May 17;283(19):2529-36. Erratum in: JAMA 2000 Nov 15;284(19):2450. JAMA 2001 Nov 22-29;284(20):2597. — View Citation

Gorman JM. A 28-year-old woman with panic disorder. JAMA. 2001 Jul 25;286(4):450-7. — View Citation

Grilo CM, Money R, Barlow DH, Goddard AW, Gorman JM, Hofmann SG, Papp LA, Shear MK, Woods SW. Pretreatment patient factors predicting attrition from a multicenter randomized controlled treatment study for panic disorder. Compr Psychiatry. 1998 Nov-Dec;39(6):323-32. — View Citation

Hofmann SG, Barlow DH, Papp LA, Detweiler MF, Ray SE, Shear MK, Woods SW, Gorman JM. Pretreatment attrition in a comparative treatment outcome study on panic disorder. Am J Psychiatry. 1998 Jan;155(1):43-7. — View Citation

Huppert JD, Bufka LF, Barlow DH, Gorman JM, Shear MK, Woods SW. Therapists, therapist variables, and cognitive-behavioral therapy outcome in a multicenter trial for panic disorder. J Consult Clin Psychol. 2001 Oct;69(5):747-55. — View Citation

Shear MK, Brown TA, Barlow DH, Money R, Sholomskas DE, Woods SW, Gorman JM, Papp LA. Multicenter collaborative panic disorder severity scale. Am J Psychiatry. 1997 Nov;154(11):1571-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Panic Disorder Severity Scale	This is a 7-item scale providing ratings of core features of panic disorder and the degree of work and social impairment/interference due to the disorder.	At baseline and major assessment points plus monthly.	No
Primary	Clinical Global Impressions	Commonly used global rating of improvement.	Monthly, including all nonpretreatment major assessments.	No
Secondary	Albany Panic and Phobia Questionnaire	This is a 27-item scale consisting of three subscales that assess fear of agoraphobic situations, social situations, and situations and activities that produce bodily sensations commonly feared by individuals with panic disorder.	All major assessment points.	No
Secondary	Anxiety Sensitivity Index	This is a 16-item scale that assesses person's tendency to regard physiologic arousal as harmful.	All major assessments and treatment visits.	No
Secondary	Subjective Symptoms Scale	This is an individual's rating of the extent to which anxiety symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships.	All major assessment points	No

External Links

•   Center for Anxiety and Related Disorders [Boston Study Site]
•   Yale Anxiety Disorders Research Clinic [New Haven Study site]