Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00057551
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2003-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Research Evaluating the Value of Augmenting Medication With Psychotherapy
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
CBASP Augmentation for Treatment of Chronic Depression
Status:
COMPLETED
Status Verified Date:
2017-11
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:
REVAMP
Brief Summary:
This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.
Detailed Description:
Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.
Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.
Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01MH062475 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH061504 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH061562 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH061587 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH061590 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH062465 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH062491 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH062546 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01MH063481 | NIH | None | https://reporter.nih.gov/quic… | View |