Clinical trial NCT00057577: Prevention of Recurrence in Depression With Drugs and CT
Official title: Prevention of Recurrence in Depression With Drugs and CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-04-08
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)
timeFrame: Through month 18 of treatment
measure: Number of Participants in Recovery According to the LIFE and HRSD
timeFrame: Through 36 months of treatment
measure: Number of Participants in Recurrence According to the LIFE and HRSD
timeFrame: Measured up to Month 36 from recovery
Secondary outcomes:
Other outcomes:
measure: Serious Adverse Events
timeFrame: Throughout study, up to 54 months
Locations:
city: Chicago
country: United States
facility: Rush Medical Center - Treatment Research Unit
state: Illinois
city: Philadelphia
country: United States
facility: Depression Research Unit, University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Adult Outpatient Psychiatry
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Steven D. Hollon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Robert J. DeRubeis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush Medical Center
name: Jan A. Fawcett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khazanov GK, Xu C, Hollon SD, DeRubeis RJ, Thase ME. Adding cognitive therapy to antidepressant medications decreases suicidal ideation. J Affect Disord. 2021 Feb 15;281:183-191. doi: 10.1016/j.jad.2020.12.032. Epub 2020 Dec 8.
citation: Khazanov GK, Xu C, Dunn BD, Cohen ZD, DeRubeis RJ, Hollon SD. Distress and anhedonia as predictors of depression treatment outcome: A secondary analysis of a randomized clinical trial. Behav Res Ther. 2020 Feb;125:103507. doi: 10.1016/j.brat.2019.103507. Epub 2019 Oct 31.
citation: DeRubeis RJ, Zajecka J, Shelton RC, Amsterdam JD, Fawcett J, Xu C, Young PR, Gallop R, Hollon SD. Prevention of Recurrence After Recovery From a Major Depressive Episode With Antidepressant Medication Alone or in Combination With Cognitive Behavioral Therapy: Phase 2 of a 2-Phase Randomized Clinical Trial. JAMA Psychiatry. 2020 Mar 1;77(3):237-245. doi: 10.1001/jamapsychiatry.2019.3900.
citation: 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.