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Identifying Factors That Predict Antidepressant Treatment Response

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen Mayberg, Emory University
ClinicalTrials.gov Identifier:
NCT00360399
First received: August 2, 2006
Last updated: September 15, 2014
Last verified: September 2014

August 2, 2006
September 15, 2014
August 2006
April 2015   (final data collection date for primary outcome measure)
Remission from major depressive episode [ Time Frame: Measured at Weeks 10 and 12 ] [ Designated as safety issue: No ]
Remission of depressive symptoms
Complete list of historical versions of study NCT00360399 on ClinicalTrials.gov Archive Site
  • 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 ]
Response to depression treatment
Not Provided
Not Provided
 
Identifying Factors That Predict Antidepressant Treatment Response
Predictors of Antidepressant Treatment Response: The Emory CIDAR

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Drug: Escitalopram
    Escitalopram 10 to 20 mg per day for 12 weeks
    Other Name: Lexapro
  • Drug: Duloxetine
    Duloxetine 30 to 60 mg per day for 12 weeks
    Other Name: Cymbalta
  • Behavioral: Cognitive behavioral therapy (CBT)
    CBT will include 16 one-hour sessions provided over 12 weeks.
  • Active Comparator: Escitalopram
    Participants will receive treatment with escitalopram for 12 weeks
    Intervention: Drug: Escitalopram
  • Active Comparator: Duloxetine
    Participants will receive treatment with duloxetine for 12 weeks
    Intervention: Drug: Duloxetine
  • Active Comparator: CBT
    Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
Dunlop BW, Binder EB, Cubells JF, Goodman MM, Kelley ME, Kinkead B, Kutner M, Nemeroff CB, Newport DJ, Owens MJ, Pace TW, Ritchie JC, Rivera VA, Westen D, Craighead WE, Mayberg HS. Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial. Trials. 2012 Jul 9;13:106. doi: 10.1186/1745-6215-13-106.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV)
  • Primary diagnosis of MDD, based on prominence of symptoms and target for intervention (comorbid anxiety disorders, except obsessive-compulsive disorder (OCD), will not be criteria for exclusion)
  • Score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
  • Agrees to use an effective form of contraception and/or double barrier method

Exclusion Criteria:

  • Previously treated for major depression with either medication or psychotherapy
  • Current psychosis, dementia, eating disorder, or dissociative disorder
  • History of bipolar disorder (I and II) or schizophrenia
  • Alcohol or drug dependence within 3 months prior to study entry or current alcohol or drug abuse (excluding nicotine and caffeine), as assessed by medical history and urine drug screening
  • Requires neuroleptic or mood stabilizer therapy in addition to depression treatment
  • Presence of any acute or chronic medical disorder that could affect successful completion of the trial
  • Medical contraindications that would preclude treatment with escitalopram or duloxetine
  • Presence of practical issues that would likely prevent completion of the study (e.g., planned geographical relocation)
  • Pregnant or breastfeeding
  • Medical conditions that could prevent the safe use of MRI (e.g., pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants; steel worker)
  • Medical conditions that could prevent the safe completion of a dexamethasone-corticotropin releasing factor (Dex-CRF) test (e.g., uncontrolled hypertension, significant abnormalities in EKG, anemia, known allergies against drugs)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00360399
IRB00024975, P50MH077083
Yes
Helen Mayberg, Emory University
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Helen S. Mayberg, MD Emory University
Principal Investigator: W. Edward Craighead, PhD Emory University
Emory University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP