Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
379 participants
INTERVENTIONAL
1999-02-28
2004-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Cognitive behavior therapy
Paroxetine or other medication - algorithm used
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Natalia A. Skritskaya, PhD
Co-investigator
Principal Investigators
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Katherine H. Shear, MD
Role: STUDY_CHAIR
University of Pittsburgh
David H Barlow, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University Department of Psychology
Jack Gorman, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University School of Medicine
Scott Woods, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic
New Haven, Connecticut, United States
Boston University, Department of Psychology, Center for Anxiety and Related Disorders
Boston, Massachusetts, 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, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Center for Anxiety and Related Disorders \[Boston Study Site\]
Yale Anxiety Disorders Research Clinic \[New Haven Study site\]
Other Identifiers
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DSIR AT-CT
Identifier Type: -
Identifier Source: secondary_id
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