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Trial NCT00000368

Resource URI: http://static.linkedct.org/resource/trials/NCT00000368
linkedct:brief_title Treatment of Panic Disorder: Long Term Strategies
linkedct:condition <http://static.linkedct.org/resource/condition/685>
linkedct:condition <http://static.linkedct.org/resource/condition/9622>
linkedct:criteria Inclusion Criteria: Patients must have: Panic disorder with or without Agoraphobia. All levels of agoraphobia are included.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date January 2004
linkedct:enrollment 366 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000368
rdfs:label Trial NCT00000368
linkedct:lastchanged_date October 20, 2006
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/135742>
linkedct:location <http://static.linkedct.org/resource/location/139388>
linkedct:location <http://static.linkedct.org/resource/location/141898>
linkedct:location <http://static.linkedct.org/resource/location/157932>
linkedct:nct_id NCT00000368
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id R01 MH45964
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/12309>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/24475>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/31985>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53443>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000368>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/10747>
linkedct:reference <http://static.linkedct.org/resource/reference/11586>
linkedct:reference <http://static.linkedct.org/resource/reference/53253>
linkedct:reference <http://static.linkedct.org/resource/reference/53620>
linkedct:reference <http://static.linkedct.org/resource/reference/55520>
linkedct:reference <http://static.linkedct.org/resource/reference/7163>
linkedct:secondary_id DSIR AT-CT
linkedct:secondary_id R01 MH45963
linkedct:secondary_id R01 MH45965
linkedct:secondary_id R01 MH45966
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date February 1999
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date November 2005