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Prevention of Recurrence in Depression With Drugs and CT (CPT3)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven Hollon, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00057577
First received: April 4, 2003
Last updated: April 1, 2015
Last verified: April 2015

April 4, 2003
April 1, 2015
October 2002
July 2012   (final data collection date for primary outcome measure)
  • Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) [ Time Frame: Through month 18 of treatment ] [ Designated as safety issue: No ]
    Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)
  • Number of Participants in Recovery According to the LIFE and HRSD [ Time Frame: Through 36 months of treatment ] [ Designated as safety issue: No ]
    Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)
  • Number of Participants in Recurrence According to the LIFE and HRSD [ Time Frame: Measured up to Month 36 from recovery ] [ Designated as safety issue: No ]
    Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)
Not Provided
Complete list of historical versions of study NCT00057577 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Serious Adverse Events [ Time Frame: Thorought study ] [ Designated as safety issue: Yes ]
Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study
Not Provided
 
Prevention of Recurrence in Depression With Drugs and CT
Prevention of Recurrence in Depression With Drugs and CT
This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression.

Participants are randomly assigned to receive either ADM alone or ADM plus CT for up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue cognitive therapy; all recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Depression
  • Behavioral: Cognitive Therapy
    CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
    Other Name: CT
  • Drug: Medications
    Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
    Other Name: ADM
  • Experimental: Cognitive therapy plus medications
    Participants will receive antidepressant medication plus cognitive therapy
    Interventions:
    • Behavioral: Cognitive Therapy
    • Drug: Medications
  • Experimental: Medications alone
    Participants will receive maintenance of antidepressant medication alone
    Intervention: Drug: Medications
Hollon SD, DeRubeis RJ, Fawcett J, Amsterdam JD, Shelton RC, Zajecka J, Young PR, Gallop R. Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1157-64. doi: 10.1001/jamapsychiatry.2014.1054. Erratum in: JAMA Psychiatry. 2016 Jun 1;73(6):639-40.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
452
March 2014
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Recurrent or chronic major depressive disorder

Exclusion Criteria:

  • Current diagnosis of psychotic affective disorder
  • History of nonaffective psychotic disorder
  • Substance dependence last three months requiring detox
  • Schizotypal, antisocial, or borderline personality disorder
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057577
R01MH060713, R01MH060713
Yes
Not Provided
Not Provided
Steven Hollon, Vanderbilt University
Vanderbilt University
National Institute of Mental Health (NIMH)
Principal Investigator: Steven D. Hollon, PhD Vanderbilt University
Principal Investigator: Robert J. DeRubeis, PhD University of Pennsylvania
Principal Investigator: Jan A. Fawcett, MD Rush Medical Center
Vanderbilt University
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP