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| ID | Type | Description | Link |
|---|---|---|---|
| U01MH062475 | U.S. NIH Grant/Contract | View source | |
| U01MH061504 | U.S. NIH Grant/Contract | View source | |
| U01MH061562 | U.S. NIH Grant/Contract | View source | |
| U01MH061587 | U.S. NIH Grant/Contract | View source | |
| U01MH061590 | U.S. NIH Grant/Contract | View source | |
| U01MH062465 | U.S. NIH Grant/Contract | View source | |
| U01MH062491 | U.S. NIH Grant/Contract | View source | |
| U01MH062546 | U.S. NIH Grant/Contract | View source | |
| U01MH063481 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBASP | Experimental | Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) |
|
| Brief Supportive Psychotherapy | Active Comparator | Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) |
|
| Medication Only | Active Comparator | Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Supportive Psychotherapy | Behavioral | brief supportive psychotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission | Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits | 12 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| James H Kocsis | weill cornell mc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724-5002 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10816183 | Background | 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. | |
| 9831997 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBASP | Cognitive Behavioral Analysis System of Psychotherapy |
| FG001 | BriefSP | Brief Supportive Psychotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| CBASP | Behavioral | psychotherapy developed for chronic depression |
|
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| Medication Only | Drug | antidepressant medication |
|
|
| Palo Alto |
| California |
| 94305 |
| United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Weill-Cornell Medical College Payne Whitney Clinic | New York | New York | 10021 | United States |
| SUNY- Stony Brook | New York | New York | 11794 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213-2600 | United States |
| Brown University | Providence | Rhode Island | 02906 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| 12858425 | Background | 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. |
| 28068460 | Derived | 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. |
| 23102821 | Derived | 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. |
| 21500885 | Derived | 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. |
| 19884606 | Derived | 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. |
| FG002 |
| Medication Only |
An algorithm including Sertraline, Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBASP | Cognitive Behavioral Analysis System of Psychotherapy |
| BG001 | Brief Supportive P | Brief Supportive Psychotherapyherapy |
| BG002 | Medication Only | Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hamilton Depression Scale | Scores range from 0-72 with higher scores indicating more severe depression | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Remission | Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits | Refers to # of subjects who completed 12 weeks of treatment | Posted | Number | percentage of participants | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBASP | Cognitive Behavioral Analysis System of Psychotherapy | 0 | 200 | 28 | 200 | ||
| EG001 | BriefSP | Supportive Therapy | 0 | 195 | 23 | 195 | ||
| EG002 | Medication | Sertraline Escitalopram Bupropion SR or XL Venlafaxine XR Mirtazapine | 0 | 96 | 8 | 96 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| moderate burden | Psychiatric disorders | FISER | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James H. Kocsis, M.D. | Weill Cornell Medical College | 212-746-5913 | jhk2002@med.cornell.edu |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Male |
|