| April 4, 2003 |
| June 16, 2006 |
| April 2003 |
| |
| |
| |
| Complete list of historical versions of study NCT00057551 on ClinicalTrials.gov Archive Site |
| |
| |
| |
| Research Evaluating the Value of Augmenting Medication With Psychotherapy (REVAMP) |
| 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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
- Depression
- Depressive Disorder
|
- Behavioral: Supportive Therapy
- Behavioral: Cognitive Behavioral Analysis System of Psychotherapy
- Drug: Sertraline
- Drug: Escitalopram
- Drug: Bupropion SR or XL
- Drug: Venlafaxine XR
- Drug: Mirtazapine
|
| |
- 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.
- 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.
- 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.
|
| |
| Active, not recruiting |
| 909 |
| March 2006 |
|
Inclusion Criteria
- Major depressive episode
- Depressive symptoms > 2 years without remission
- 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 antisocical, 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
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00057551 |
|
| U01 MH62475, DSIR 83-ATSO, U01 MH61504, U01 MH61562, U01 MH61587, U01 MH61590, U01 MH62465, U01 MH62491, U01 MH62546, U01 MH63481 |
| National Institute of Mental Health (NIMH) |
|
| Investigator: |
James P. McCullough, Ph.D. |
Virginia Commonwealth University |
|
|
| National Institute of Mental Health (NIMH) |
| June 2006 |