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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH060713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive therapy plus medications | Experimental | Participants will receive antidepressant medication plus cognitive therapy |
|
| Medications alone | Experimental | Participants will receive maintenance of antidepressant medication alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Therapy | Behavioral | 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. |
| 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) | 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 |
| Number of Participants in Recovery According to the LIFE and HRSD | 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) | Through 36 months of treatment |
| Number of Participants in Recurrence According to the LIFE and HRSD | 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) | Measured up to Month 36 from recovery |
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| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study | Throughout study, up to 54 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven D. Hollon, PhD | Vanderbilt University | Principal Investigator |
| Robert J. DeRubeis, PhD | University of Pennsylvania | Principal Investigator |
| Jan A. Fawcett, MD | Rush Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush Medical Center - Treatment Research Unit | Chicago | Illinois | 60612 | United States | ||
| Depression Research Unit, University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33326891 | Derived | 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. | |
| 31896529 | Derived | 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. |
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Recruitment into the study started in October 2002 and the last of the 452 patients randomized completed up to three years of treatment and a subsequent three your maintenance/follow-up in July 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Therapy Plus Antidepressant Medications | Participants will receive antidepressant medication plus cognitive therapy Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT. Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 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. |
| FG001 | Antidepressant Medications Alone | Participants will receive maintenance of antidepressant medication alone Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants met criteria for Major Depressive Disorder (MDD) with exclusions only for psychosis and selected personality disorders
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Therapy Plus Antidepressant Medications | Participants will receive antidepressant medication plus cognitive therapy 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) | 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) | Posted | Number | number participants that reach remission | Through month 18 of treatment |
|
Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Therapy Plus Antidepressant Medications | Participants will receive antidepressant medication plus cognitive therapy 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (any cause) | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven D. Hollon | Vanderbilt University | 615-322-3369 | steven.d.hollon@vanderbilt.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004364 | Pharmaceutical Preparations |
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|
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| Medications | Drug | 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. |
|
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Vanderbilt Adult Outpatient Psychiatry | Nashville | Tennessee | 37203 | United States |
| 31799993 | Derived | 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. |
| 25142196 | Derived | 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. |
|
| BG001 | Antidepressant Medications Alone | Participants will receive maintenance of antidepressant medication alone 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of participants who met criteria for Major Depressive Disorder via SCID-MDD | Number | participants |
|
| OG001 | Antidepressant Medications Alone | Participants will receive maintenance of antidepressant medication alone 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. |
|
|
|
| Primary | Number of Participants in Recovery According to the LIFE and HRSD | 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) | Posted | Number | number participants that reach recovery | Through 36 months of treatment |
|
|
|
|
| Primary | Number of Participants in Recurrence According to the LIFE and HRSD | 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) | Posted | Count of Participants | Participants | Measured up to Month 36 from recovery |
|
|
|
| Other Pre-specified | Serious Adverse Events | Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study | Posted | Number | number of SAE's | Throughout study, up to 54 months |
|
|
|
| 59 |
| 227 |
| 0 |
| 227 |
| EG001 | Antidepressant Medications Alone | Participants will receive maintenance of antidepressant medication alone 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. | 82 | 225 | 0 | 225 |
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Psychiatric Hospitalizations | Psychiatric disorders | Non-systematic Assessment |
|
| Medical Hospitalizations | General disorders | Non-systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Motor Vehicle Accidents (MVA) | General disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
|
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| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |