Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000368
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
1999-11-02
Brief Title:
Treatment of Panic Disorder Long Term Strategies
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Treatment of Panic Disorder Long Term Strategies
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 heshe 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 heshe has panic disorder with no more than mild agoraphobia fear of being in public places and is at least 18 years old
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 heshe 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 heshe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR AT-CT | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH045963 |
| R01MH045964 | NIH | None | None |
| R01MH045965 | NIH | None | None |
| R01MH045966 | NIH | None | None |
| R01MH045963 | NIH | None | None |