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DepressionPhase 4REVAMPNCT00057551

Research Evaluating the Value of Augmenting Medication With Psychotherapy

A Phase 4 study testing Brief Supportive Psychotherapy, CBASP and Medication Only in people with Depression and Depressive Disorder, run by Weill Medical College of Cornell University at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depression, Depressive Disorder
What is being tested?
Brief Supportive Psychotherapy, CBASP and Medication Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
491 participants
Where
8 sitesUnited States
Study dates
Apr 2003to Mar 2007
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Major depressive episode
  • Depressive symptoms > 2 years without remission
  • Hamilton Depression Scale (HAM-D) score > 20
  • Fluent in English

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Emory University

    Atlanta, Georgia, 30329

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235

  • Weill-Cornell Medical College Payne Whitney Clinic

    New York, New York, 10021

  • SUNY- Stony Brook

    New York, New York, 11794

  • Stanford University

    Palo Alto, California, 94305

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213-2600

  • Brown University

    Providence, Rhode Island, 02906

  • University of Arizona

    Tucson, Arizona, 85724-5002

Other trials in United States

About this study

Official title: CBASP Augmentation for Treatment of Chronic Depression

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.

Read the 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.

Being tested
Brief Supportive Psychotherapy, CBASP, Medication Only
Medical subject headings
Depression, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Supportive PsychotherapyBehavioural

    brief supportive psychotherapy

  • CBASPBehavioural

    Also called Cognitive Behavioral Analysis System of Psychotherapy

    psychotherapy developed for chronic depression

  • Medication OnlyDrug

    Also called one of five antidepressants

    antidepressant medication

Study groups in NCT00057551
Study groupRoleWhat they receive
CBASPExperimentalCognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Receives: Behavioral: CBASP
Brief Supportive PsychotherapyActive comparatorBrief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Receives: Behavioral: Brief Supportive Psychotherapy
Medication OnlyActive comparatorCould be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
Receives: Drug: Medication Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
491 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057551
Sponsor's protocol ID
U01MH062475
Other IDs
U01MH062475, U01MH061504, U01MH061562, U01MH061587, U01MH061590, U01MH062465, U01MH062491, U01MH062546
Acronym
REVAMP
Status last verified
Nov 2017
First submitted
4 Apr 2003
Last updated
6 Dec 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 10816183

  • 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.

    PubMed 9831997

  • 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.

    PubMed 12858425

  • Yasinski C, Ma T, Thase ME, Kocsis JH, Arnow BA, Keller MB, Klein DN, Manber R, Markowitz JC, Rothbaum BO, Trivedi MH, Dunlop BW. Remission status in persistent depressive disorder following acute treatment with psychotherapy plus medication or medication alone: A 2-year naturalistic follow-up. J Affect Disord. 2026 Sep 13:122506. doi: 10.1016/j.jad.2026.122506. Online ahead of print.

    PubMed 42732834

  • 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.

    PubMed 28068460

  • 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.

    PubMed 23102821

  • 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.

    PubMed 21500885

  • 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.

    PubMed 19884606

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brief Supportive Psychotherapy, CBASP and Medication Only in people with Depression and Depressive Disorder, run by Weill Medical College of Cornell University at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00057551, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.

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