Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004834
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2000-02-24
Brief Title:
Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-02
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:
OBJECTIVES
I Determine which treatment is most effective for patients with panic disorder cognitive-behavioral therapy CBT plus imipramine IMI CBT plus placebo CBT alone IMI alone or placebo alone
I Determine which treatment is most effective for patients with panic disorder cognitive-behavioral therapy CBT plus imipramine IMI CBT plus placebo CBT alone IMI alone or placebo alone
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to receive one of five treatments cognitive-behavioral therapy CBT alone imipramine plus medical management IMI CBT plus IMI pill placebo plus medical management PLA or CBT plus PLA
Patients are seen by therapists for 11 sessions over 12 weeks 3 sessions during days 1-10 followed by 6 weekly sessions and 2 biweekly sessions Each CBT session lasts approximately 1 hour each IMI session lasts approximately 30 minutes and patients in combined treatment see 2 therapists for a total of about 80 minutes Oral IMI or placebo is taken daily
Patients not responding to placebo or IMI after the initial 12 weeks are offered alternative treatment for up to 3 months or given a referral responders continue to be treated monthly for the next 6 months This is followed by a washout period of 6 months after which patients receive final assessment All therapy and assessment sessions are video- or audiotaped
Patients are interviewed by an independent evaluator at the start of treatment and 3 9 and 15 months later and must keep a set of weekly self-monitoring forms In addition patients complete rating forms and questionnaires and undergo carbon dioxide measurement at the start of treatment and 3 9 and 15 months later
At study conclusion patients are told which medication they received and receive treatment recommendations
Patients are seen by therapists for 11 sessions over 12 weeks 3 sessions during days 1-10 followed by 6 weekly sessions and 2 biweekly sessions Each CBT session lasts approximately 1 hour each IMI session lasts approximately 30 minutes and patients in combined treatment see 2 therapists for a total of about 80 minutes Oral IMI or placebo is taken daily
Patients not responding to placebo or IMI after the initial 12 weeks are offered alternative treatment for up to 3 months or given a referral responders continue to be treated monthly for the next 6 months This is followed by a washout period of 6 months after which patients receive final assessment All therapy and assessment sessions are video- or audiotaped
Patients are interviewed by an independent evaluator at the start of treatment and 3 9 and 15 months later and must keep a set of weekly self-monitoring forms In addition patients complete rating forms and questionnaires and undergo carbon dioxide measurement at the start of treatment and 3 9 and 15 months later
At study conclusion patients are told which medication they received and receive treatment recommendations
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R10MH045963 | NIH | None | None |
| R10MH045965 | NIH | None | None |
| R10MH045964 | NIH | None | None |
| R10MH045966 | NIH | None | httpsreporternihgovquickSearchR10MH045966 |