- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057577
Prevention of Recurrence in Depression With Drugs and CT (CPT3)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Medical Center - Treatment Research Unit
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Depression Research Unit, University of Pennsylvania
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt Adult Outpatient Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive therapy plus medications
Participants will receive antidepressant medication plus 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 Names:
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 Names:
|
Experimental: Medications alone
Participants will receive maintenance of antidepressant medication alone
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
Through month 18 of treatment
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Number of Participants in Recovery According to the LIFE and HRSD
Time Frame: Through 36 months of treatment
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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)
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Through 36 months of treatment
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Number of Participants in Recurrence According to the LIFE and HRSD
Time Frame: Measured up to Month 36 from recovery
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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)
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Measured up to Month 36 from recovery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serious Adverse Events
Time Frame: Throughout study, up to 54 months
|
Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study
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Throughout study, up to 54 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven D. Hollon, PhD, Vanderbilt University
- Principal Investigator: Jan A. Fawcett, MD, Rush Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: JAMA Psychiatry. 2020 Jan 29;:
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH060713 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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