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Research Evaluating the Value of Augmenting Medication With Psychotherapy (REVAMP)

Primary Purpose

Depression, Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brief Supportive Psychotherapy
CBASP
Medication Only
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Major depressive episode Depressive symptoms > 2 years without remission Hamilton Depression Scale (HAM-D) score > 20 Fluent in English Exclusion Criteria Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder Serious, unstable, or terminal medical condition Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder Previous treatment with CBASP Previous ineffective treatment with 4 of the medication treatments used in the study Substance abuse Pregnancy Not willing to end other psychiatric treatment

Sites / Locations

  • University of Arizona
  • Stanford University
  • Emory University
  • Weill-Cornell Medical College Payne Whitney Clinic
  • SUNY- Stony Brook
  • University of Pittsburgh
  • Brown University
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CBASP

Brief Supportive Psychotherapy

Medication Only

Arm Description

Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)

Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)

Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine

Outcomes

Primary Outcome Measures

Remission
Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits

Secondary Outcome Measures

Full Information

First Posted
April 4, 2003
Last Updated
November 1, 2017
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00057551
Brief Title
Research Evaluating the Value of Augmenting Medication With Psychotherapy
Acronym
REVAMP
Official Title
CBASP Augmentation for Treatment of Chronic Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
491 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBASP
Arm Type
Experimental
Arm Description
Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Arm Title
Brief Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Arm Title
Medication Only
Arm Type
Active Comparator
Arm Description
Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
Intervention Type
Behavioral
Intervention Name(s)
Brief Supportive Psychotherapy
Intervention Description
brief supportive psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
CBASP
Other Intervention Name(s)
Cognitive Behavioral Analysis System of Psychotherapy
Intervention Description
psychotherapy developed for chronic depression
Intervention Type
Drug
Intervention Name(s)
Medication Only
Other Intervention Name(s)
one of five antidepressants
Intervention Description
antidepressant medication
Primary Outcome Measure Information:
Title
Remission
Description
Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Major depressive episode Depressive symptoms > 2 years without remission Hamilton Depression Scale (HAM-D) score > 20 Fluent in English Exclusion Criteria Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder Serious, unstable, or terminal medical condition Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder Previous treatment with CBASP Previous ineffective treatment with 4 of the medication treatments used in the study Substance abuse Pregnancy Not willing to end other psychiatric treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Kocsis
Organizational Affiliation
weill cornell mc
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5002
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Weill-Cornell Medical College Payne Whitney Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY- Stony Brook
City
New York
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2600
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10816183
Citation
Keller MB, McCullough JP, Klein DN, Arnow B, Dunner DL, Gelenberg AJ, Markowitz JC, Nemeroff CB, Russell JM, Thase ME, Trivedi MH, Zajecka J. A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med. 2000 May 18;342(20):1462-70. doi: 10.1056/NEJM200005183422001. Erratum In: N Engl J Med 2001 Jul 19;345(3):232.
Results Reference
background
PubMed Identifier
9831997
Citation
Keller MB, Kocsis JH, Thase ME, Gelenberg AJ, Rush AJ, Koran L, Schatzberg A, Russell J, Hirschfeld R, Klein D, McCullough JP, Fawcett JA, Kornstein S, LaVange L, Harrison W. Maintenance phase efficacy of sertraline for chronic depression: a randomized controlled trial. JAMA. 1998 Nov 18;280(19):1665-72. doi: 10.1001/jama.280.19.1665.
Results Reference
background
PubMed Identifier
12858425
Citation
McCullough JP Jr. Treatment for chronic depression using Cognitive Behavioral Analysis System of Psychotherapy (CBASP). J Clin Psychol. 2003 Aug;59(8):833-46. doi: 10.1002/jclp.10176.
Results Reference
background
PubMed Identifier
28068460
Citation
Shankman SA, Gorka SM, Katz AC, Klein DN, Markowitz JC, Arnow BA, Manber R, Rothbaum BO, Thase ME, Schatzberg AF, Keller MB, Trivedi MH, Kocsis JH. Side Effects to Antidepressant Treatment in Patients With Depression and Comorbid Panic Disorder. J Clin Psychiatry. 2017 Apr;78(4):433-440. doi: 10.4088/JCP.15m10370.
Results Reference
derived
PubMed Identifier
23102821
Citation
Shankman SA, Campbell ML, Klein DN, Leon AC, Arnow BA, Manber R, Keller MB, Markowitz JC, Rothbaum BO, Thase ME, Kocsis JH. Dysfunctional attitudes as a moderator of pharmacotherapy and psychotherapy for chronic depression. J Psychiatr Res. 2013 Jan;47(1):113-21. doi: 10.1016/j.jpsychires.2012.09.018. Epub 2012 Oct 25.
Results Reference
derived
PubMed Identifier
21500885
Citation
Klein DN, Leon AC, Li C, D'Zurilla TJ, Black SR, Vivian D, Dowling F, Arnow BA, Manber R, Markowitz JC, Kocsis JH. Social problem solving and depressive symptoms over time: a randomized clinical trial of cognitive-behavioral analysis system of psychotherapy, brief supportive psychotherapy, and pharmacotherapy. J Consult Clin Psychol. 2011 Jun;79(3):342-52. doi: 10.1037/a0023208.
Results Reference
derived
PubMed Identifier
19884606
Citation
Kocsis JH, Gelenberg AJ, Rothbaum BO, Klein DN, Trivedi MH, Manber R, Keller MB, Leon AC, Wisniewski SR, Arnow BA, Markowitz JC, Thase ME; REVAMP Investigators. Cognitive behavioral analysis system of psychotherapy and brief supportive psychotherapy for augmentation of antidepressant nonresponse in chronic depression: the REVAMP Trial. Arch Gen Psychiatry. 2009 Nov;66(11):1178-88. doi: 10.1001/archgenpsychiatry.2009.144.
Results Reference
derived

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Research Evaluating the Value of Augmenting Medication With Psychotherapy

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