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Preventing the Recurrence of Depression With Drugs and Psychotherapy

This study is ongoing, but not recruiting participants.
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: March 26, 2013
Last verified: March 2013
History of Changes

April 4, 2003
March 26, 2013
October 2002
July 2012   (final data collection date for primary outcome measure)
  • Time to remission (LIFE and HRSD) [ Time Frame: Measured at Month 18 of treatment ] [ Designated as safety issue: No ]
  • Time to recovery (LIFE and HRSD) [ Time Frame: Measured at Month 36 of treatment ] [ Designated as safety issue: No ]
  • Time to recurrence (LIFE and HRSD) [ Time Frame: Measured up to Month 36 from recovery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00057577 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
serious adverse events [ Time Frame: throught the trial ] [ Designated as safety issue: Yes ]
serious adverse events as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study
Not Provided
 
Preventing the Recurrence of Depression With Drugs and Psychotherapy
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)
    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: Antidepressant 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.
  • Experimental: 1
    Participants will receive antidepressant medication plus cognitive therapy
    Interventions:
    • Behavioral: Cognitive Therapy (CT)
    • Drug: Antidepressant medications
  • Experimental: 2
    Participants will receive maintenance of antidepressant medication alone
    Intervention: Drug: Antidepressant medications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057577
R01 MH60713, R01MH060713, DSIR 83-ATAS
Yes
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
March 2013

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