NCT00057551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Apr 2003

Typical duration for phase_4 depression

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

June 10, 2016

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3.9 years

First QC Date

April 4, 2003

Results QC Date

April 7, 2015

Last Update Submit

November 1, 2017

Conditions

DepressionDepressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Remission

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

    12 weeks

Study Arms (3)

CBASP

EXPERIMENTAL

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

Behavioral: CBASP

Brief Supportive Psychotherapy

ACTIVE COMPARATOR

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

Behavioral: Brief Supportive Psychotherapy

Medication Only

ACTIVE COMPARATOR

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

Drug: Medication Only

Interventions

Brief Supportive PsychotherapyBEHAVIORAL

brief supportive psychotherapy

Brief Supportive Psychotherapy
CBASPBEHAVIORAL

psychotherapy developed for chronic depression

Also known as: Cognitive Behavioral Analysis System of Psychotherapy
CBASP
Medication OnlyDRUG

antidepressant medication

Also known as: one of five antidepressants
Medication Only

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Arizona

Tucson, Arizona, 85724-5002, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Weill-Cornell Medical College Payne Whitney Clinic

New York, New York, 10021, United States

Location

SUNY- Stony Brook

New York, New York, 11794, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213-2600, United States

Location

Brown University

Providence, Rhode Island, 02906, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (7)

  • 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.

    PMID: 10816183BACKGROUND

  • 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.

    PMID: 9831997BACKGROUND

  • 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.

    PMID: 12858425BACKGROUND

  • 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.

    PMID: 28068460DERIVED

  • 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.

    PMID: 23102821DERIVED

  • 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.

    PMID: 21500885DERIVED

  • 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.

    PMID: 19884606DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Results Point of Contact

Title
James H. Kocsis, M.D.
Organization
Weill Cornell Medical College
jhk2002@med.cornell.edu
212-746-5913

Study Officials

  • James H Kocsis

    weill cornell mc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2003

First Posted

April 7, 2003

Study Start

April 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 6, 2017

Results First Posted

June 10, 2016

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(8)