Identifying Factors That Predict Antidepressant Treatment Response
This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.
Behavioral: Cognitive behavioral therapy (CBT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Predictors of Antidepressant Treatment Response: The Emory CIDAR|
- Remission from major depressive episode [ Time Frame: Measured at Weeks 10 and 12 ] [ Designated as safety issue: No ]
- Response to treatment of depressive symptoms [ Time Frame: Measured at Weeks 10 and 12 ] [ Designated as safety issue: No ]
- Rate and probability of relapse and recurrence following remission to monotherapy treatments [ Time Frame: Measured at 6, 12, 15, 18 and 24 months ] [ Designated as safety issue: No ]
- Remission from major depressive episode after 12 weeks of combined antidepressant and CBT treatments for those patients who do not remit with monotherapy [ Time Frame: Measured after 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Escitalopram
Participants will receive treatment with escitalopram for 12 weeks
Escitalopram 10 to 20 mg per day for 12 weeks
Other Name: Lexapro
Active Comparator: Duloxetine
Participants will receive treatment with duloxetine for 12 weeks
Duloxetine 30 to 60 mg per day for 12 weeks
Other Name: Cymbalta
Active Comparator: CBT
Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 16 one-hour sessions provided over 12 weeks.
Major depressive disorder (MDD) is a serious illness that affects a person's body, mood, and thoughts. The symptoms of MDD can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Antidepressant medications and psychotherapy are among the effective treatments for MDD. Individuals often respond to one type of treatment, but not another. Currently, however, doctors have no way of pre-determining which individuals will most benefit from which treatments. In the absence of practical predictors of MDD treatment response, the potential efficacy of existing MDD treatments is limited. This study will identify factors that may predict MDD treatment response by comparing the effectiveness of a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), and cognitive behavioral therapy in people with MDD.
Participants in this 14-week, double-blind study will be randomly assigned to receive duloxetine (SNRI), escitalopram (SSRI), or cognitive behavioral therapy. During the first 2 weeks of screening, participants will complete questionnaires, clinician evaluations, an electrocardiogram, a personality assessment, a dexamethasone-corticotropin releasing factor test, a functional magnetic resonance imaging scan and provide blood samples. Upon completion of screening, patients will start the treatment to which they were randomized. Duloxetine and escitalopram are two medications that are approved by the Food and Drug Administration for the treatment of depression. Cognitive behavioral therapy is a talking therapy that is also used to treat depression. All participants assigned to take duloxetine or escitalopram will be seen by a study physician weekly for 6 weeks, and then every other week for the remainder of the study. Participants assigned to cognitive behavioral therapy will attend therapy sessions twice a week for the first 4 weeks, and then once a week for the remainder of the study. The following assessments will be performed for all participants at each visit: vital sign and weight measurements; clinician assessments; and self-report questionnaires. Additionally, blood samples will be taken at three visits through the trial and functional magnetic resonance imaging (fMRI) scans will be performed at selected times.
A companion study to the main CIDAR study offers participants further treatment. Participants who achieve remission after the initial 12 weeks of treatment will have the option to enroll in a 21-month follow-up study of maintenance treatment, with visits every three months to monitor for sustained response and relapse. Participants who do not remit will have the option to enroll in another 12-week treatment course, receiving a combination of CBT and medication. Participants who achieve response after this combination treatment will be eligible to receive maintenance combination treatment for up to an additional 18 months, monitored for sustained response and relapse. Participants who do not wish to enroll or continue in the companion study will be provided with a referral for treatment with another mental health provider.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360399
|United States, Georgia|
|Emory University Mood and Anxiety Disorders Program|
|Atlanta, Georgia, United States, 30306|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Helen S. Mayberg, MD||Emory University|
|Principal Investigator:||W. Edward Craighead, PhD||Emory University|