Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118417
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2005-07-06
Brief Title:
Therapies for Treatment-Resistant Panic Disorder Symptoms
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Treatment Refractory Panic Disorder
Status:
COMPLETED
Status Verified Date:
2014-06
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:
This study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication
Detailed Description:
Panic disorder is a serious condition that may cause significant psychological and physical distress Many patients with panic disorder remain symptomatic despite initial intervention Unfortunately little data is available to guide health care providers in next-step treatment approaches This study will evaluate the effectiveness of treatments for individuals with panic disorder that is resistant to initial treatment with selective serotonin reuptake inhibitors SSRIs
This study will last 24 weeks and will comprise three phases In Phase 1 participants will receive the SSRI sertraline for 6 weeks Phase 1 will be used to determine participants resistance to treatment During Phase 1 participants will begin a medication schedule and symptom diary and will have weekly study visits to assess regimen adherence and any side effects they may be experiencing In Phase 2 participants will be randomly assigned to 6 weeks of one of two treatments sertraline at an elevated dose from that given in Phase 1 or a sertraline and placebo regimen During Phase 2 participants will have 3 study visits Self-report scales and diary entries will be used to assess panic disorder symptoms and medication side effects In Phase 3 participants will be randomly assigned to receive either cognitive behavioral therapy CBT or sertraline and clonazepam for 12 weeks All participants will have weekly study visits during Phase 3 Questionnaires and self-report scales will be used to assess participants at the end of Phase 3
Study hypothesis Combined selective serotonin reuptake inhibitors SSRIs and benzodiazepine treatment increasing the dose of SSRI and the addition of cognitive behavioral therapy CBT each may have benefits for patients with panic disorder who remain symptomatic after initial treatment with SSRIs
This study will last 24 weeks and will comprise three phases In Phase 1 participants will receive the SSRI sertraline for 6 weeks Phase 1 will be used to determine participants resistance to treatment During Phase 1 participants will begin a medication schedule and symptom diary and will have weekly study visits to assess regimen adherence and any side effects they may be experiencing In Phase 2 participants will be randomly assigned to 6 weeks of one of two treatments sertraline at an elevated dose from that given in Phase 1 or a sertraline and placebo regimen During Phase 2 participants will have 3 study visits Self-report scales and diary entries will be used to assess panic disorder symptoms and medication side effects In Phase 3 participants will be randomly assigned to receive either cognitive behavioral therapy CBT or sertraline and clonazepam for 12 weeks All participants will have weekly study visits during Phase 3 Questionnaires and self-report scales will be used to assess participants at the end of Phase 3
Study hypothesis Combined selective serotonin reuptake inhibitors SSRIs and benzodiazepine treatment increasing the dose of SSRI and the addition of cognitive behavioral therapy CBT each may have benefits for patients with panic disorder who remain symptomatic after initial treatment with SSRIs
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-CD | US NIH GrantContract | None | httpsreporternihgovquickSearchK23MH001831 |
| K23MH001831 | NIH | None | None |