REVAMP: Research Evaluating the Value of Augmenting Medication With Psychotherapy

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00057551
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 491
• Locations: 8
• Arms: 3
• Duration (Months): 47
• Patients Per Site: 61.4
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Depressive Disorder	Behavioral: Brief Supportive Psychotherapy; Behavioral: CBASP; Drug: Medication Only	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 491 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CBASP Augmentation for Treatment of Chronic Depression
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBASP Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)	Behavioral: CBASP; psychotherapy developed for chronic depression; Other Names: Cognitive Behavioral Analysis System of Psychotherapy
Active Comparator: Brief Supportive Psychotherapy Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)	Behavioral: Brief Supportive Psychotherapy; brief supportive psychotherapy
Active Comparator: Medication Only Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine	Drug: Medication Only; antidepressant medication; Other Names: one of five antidepressants

Outcome Measures

Primary Outcome Measures

1. Remission [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724-5002
2	Stanford University	Palo Alto	California	United States	94305
3	Emory University	Atlanta	Georgia	United States	30329
4	Weill-Cornell Medical College Payne Whitney Clinic	New York	New York	United States	10021
5	SUNY- Stony Brook	New York	New York	United States	11794
6	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213-2600
7	Brown University	Providence	Rhode Island	United States	02906
8	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75235

Sponsors and Collaborators

• Weill Medical College of Cornell University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: James H Kocsis, weill cornell mc

Study Documents (Full-Text)

None provided.

More Information

Publications

• J. P. McCullough, Jr. Treatment for Chronic Depression. Cognitive Behavioral Analysis System of Psychotherapy, New York: Guilford Press, 2000
• 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.
• 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. Erratum in: N Engl J Med 2001 Jul 19;345(3):232.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT00057551
• Other Study ID Numbers: U01MH062475; U01MH062475; U01MH061504; U01MH061562; U01MH061587; U01MH061590; U01MH062465; U01MH062491; U01MH062546; U01MH063481
• First Posted: Apr 7, 2003
• Last Update Posted: Dec 6, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Depression; Depressive Disorder; Antidepressive Agents

Study Results

Participant Flow

Arm/Group Title	CBASP	BriefSP	Medication Only
Arm/Group Description	Cognitive Behavioral Analysis System of Psychotherapy	Brief Supportive Psychotherapy	An algorithm including Sertraline, Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine
Period Title: Overall Study
STARTED	200	195	96
COMPLETED	175	168	80
NOT COMPLETED	25	27	16

Baseline Characteristics

Arm/Group Title	CBASP	Brief Supportive P	Medication Only	Total
Arm/Group Description	Cognitive Behavioral Analysis System of Psychotherapy	Brief Supportive Psychotherapyherapy	Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine	Total of all reporting groups
Overall Participants	200	195	96	491
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.2 (13.4)	46.4 (11.7)	45.3 (11.9)	45.9 (11.8)
Sex: Female, Male (Count of Participants)
Female	112 56%	113 57.9%	47 49%	272 55.4%
Male	88 44%	82 42.1%	49 51%	219 44.6%
Region of Enrollment (participants) [Number]
United States	200 100%	195 100%	96 100%	491 100%
Hamilton Depression Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	19.52 (8.26)	19.44 (8.31)	18.4 (8.8)	19.48 (8.27)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Refers to # of subjects who completed 12 weeks of treatment

Arm/Group Title	CBASP	Brief SP	Medication Only
Arm/Group Description	Cognitive Behavioral Analysis System of Psychotherapy	Supportive Therapy	Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine
Measure Participants	174	168	76
Number [percentage of participants]	38.5 19.3%	31.0 15.9%	39.5 41.1%

Adverse Events

Arm/Group Title	CBASP		BriefSP		Medication
Arm/Group Description	Cognitive Behavioral Analysis System of Psychotherapy		Supportive Therapy		Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine
All Cause Mortality
	CBASP		BriefSP		Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CBASP		BriefSP		Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/195 (0%)		0/96 (0%)
Other (Not Including Serious) Adverse Events
	CBASP		BriefSP		Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/200 (14%)		23/195 (11.8%)		8/96 (8.3%)
Psychiatric disorders
moderate burden	28/200 (14%)	28	23/195 (11.8%)	28	8/96 (8.3%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.