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Treatment of Panic Disorder: Long Term Strategies

Primary Purpose

Panic Disorder, Agoraphobia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavior therapy
Paroxetine or other medication - algorithm used
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Adult, Cognitive Behavioral Therapy, Pharmacotherapy, Long term treatment, Remission and relapse, Male, Panic Disorder, Paroxetine, Serotonin Uptake Inhibitors, Panic Disorder -- *therapy, Panic Disorder -- drug therapy, Paroxetine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic
  • Boston University, Department of Psychology, Center for Anxiety and Related Disorders
  • Hillside Hospital Phobia Clinic
  • University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program

Outcomes

Primary Outcome Measures

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.
Clinical Global Impressions
Commonly used global rating of improvement.

Secondary Outcome Measures

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.
Anxiety Sensitivity Index
This is a 16-item scale that assesses person's tendency to regard physiologic arousal as harmful.
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.

Full Information

First Posted
November 2, 1999
Last Updated
March 17, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00000368
Brief Title
Treatment of Panic Disorder: Long Term Strategies
Official Title
Treatment of Panic Disorder: Long Term Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Agoraphobia
Keywords
Adult, Cognitive Behavioral Therapy, Pharmacotherapy, Long term treatment, Remission and relapse, Male, Panic Disorder, Paroxetine, Serotonin Uptake Inhibitors, Panic Disorder -- *therapy, Panic Disorder -- drug therapy, Paroxetine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
379 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Type
Drug
Intervention Name(s)
Paroxetine or other medication - algorithm used
Primary Outcome Measure Information:
Title
Panic Disorder Severity Scale
Description
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.
Time Frame
At baseline and major assessment points plus monthly.
Title
Clinical Global Impressions
Description
Commonly used global rating of improvement.
Time Frame
Monthly, including all nonpretreatment major assessments.
Secondary Outcome Measure Information:
Title
Albany Panic and Phobia Questionnaire
Description
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.
Time Frame
All major assessment points.
Title
Anxiety Sensitivity Index
Description
This is a 16-item scale that assesses person's tendency to regard physiologic arousal as harmful.
Time Frame
All major assessments and treatment visits.
Title
Subjective Symptoms Scale
Description
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.
Time Frame
All major assessment points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine H. Shear, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David H Barlow, PhD
Organizational Affiliation
Boston University Department of Psychology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jack Gorman, MD
Organizational Affiliation
Columbia University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Woods, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Boston University, Department of Psychology, Center for Anxiety and Related Disorders
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Hillside Hospital Phobia Clinic
City
New York
State/Province
New York
Country
United States
Facility Name
University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10815116
Citation
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. doi: 10.1001/jama.283.19.2529. Erratum In: JAMA 2000 Nov 15;284(19):2450. JAMA 2001 Nov 22-29;284(20):2597.
Results Reference
background
PubMed Identifier
9356566
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. doi: 10.1176/ajp.154.11.1571.
Results Reference
background
PubMed Identifier
11466124
Citation
Gorman JM. A 28-year-old woman with panic disorder. JAMA. 2001 Jul 25;286(4):450-7. doi: 10.1001/jama.286.4.450. No abstract available.
Results Reference
background
PubMed Identifier
9829138
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. doi: 10.1016/s0010-440x(98)90043-8.
Results Reference
background
PubMed Identifier
11680551
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. doi: 10.1037//0022-006x.69.5.747.
Results Reference
background
PubMed Identifier
9433337
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. doi: 10.1176/ajp.155.1.43.
Results Reference
background
PubMed Identifier
26663632
Citation
Payne LA, White KS, Gallagher MW, Woods SW, Shear MK, Gorman JM, Farchione TJ, Barlow DH. SECOND-STAGE TREATMENTS FOR RELATIVE NONRESPONDERS TO COGNITIVE BEHAVIORAL THERAPY (CBT) FOR PANIC DISORDER WITH OR WITHOUT AGORAPHOBIA-CONTINUED CBT VERSUS SSRI: A RANDOMIZED CONTROLLED TRIAL. Depress Anxiety. 2016 May;33(5):392-9. doi: 10.1002/da.22457. Epub 2015 Dec 10.
Results Reference
derived
Links:
URL
http://www.bu.edu/anxiety/
Description
Center for Anxiety and Related Disorders [Boston Study Site]
URL
http://info.med.yale.edu/yfp/new/anxiety.html
Description
Yale Anxiety Disorders Research Clinic [New Haven Study site]

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Treatment of Panic Disorder: Long Term Strategies

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