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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
Results First Received: December 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Depression
Interventions: Behavioral: Cognitive Therapy
Drug: Medications

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Cognitive Therapy Plus Antidepressant Medications     Antidepressant Medications Alone  
STARTED     227     225  
COMPLETED     227     225  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants met criteria for Major Depressive Disorder (MDD) with exclusions only for psychosis and selected personality disorders

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
    Cognitive Therapy Plus Antidepressant Medications     Antidepressant Medications Alone     Total  
Number of Participants  
[units: participants]
  227     225     452  
Age  
[units: years]
Mean (Standard Deviation)
  43.3  (12.9)     43.0  (13.4)     43.2  (13.1)  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     214     214     428  
>=65 years     13     11     24  
Gender  
[units: participants]
     
Female     130     136     266  
Male     97     89     186  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     4     1     5  
Asian     6     4     10  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     21     27     48  
White     194     193     387  
More than one race     1     0     1  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     17     10     27  
Not Hispanic or Latino     210     215     425  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     227     225     452  
Number of participants who met criteria for Major Depressive Disorder via SCID-MDD  
[units: participants]
  227     225     452  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   Number of Participants in Recovery According to the LIFE and HRSD   [ Time Frame: Through 36 months of treatment ]

3.  Primary:   Number of Participants in Recurrence According to the LIFE and HRSD   [ Time Frame: Measured up to Month 36 from recovery ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   No

4.  Other Pre-specified:   Serious Adverse Events   [ Time Frame: Thorought study ]
Results not yet reported.   Anticipated Reporting Date:   06/2016   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven D. Hollon
Organization: Vanderbilt University
phone: 615-322-3369
e-mail: steven.d.hollon@vanderbilt.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven Hollon, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00057577     History of Changes
Other Study ID Numbers: R01MH060713 ( US NIH Grant/Contract Award Number )
Study First Received: April 4, 2003
Results First Received: December 18, 2013
Last Updated: April 1, 2015
Health Authority: United States: Federal Government