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Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression

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ClinicalTrials.gov Identifier: NCT00200902
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Eli Lilly and Company
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Andrew F. Leuchter, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 20, 2005
Results First Submitted Date  ICMJE May 25, 2018
Results First Posted Date  ICMJE April 10, 2019
Last Update Posted Date April 10, 2019
Study Start Date  ICMJE August 2005
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Response as Assessed by Participants' Change in Depression Rating [ Time Frame: Baseline, Week 8 ]
    Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.
  • Average Change in 3 Weeks of Participant Treatment Expectations [ Time Frame: Averaged over 3 time points (Baseline, randomization, and end of lead-in) ]
    Patient Attitudes and Expectations Form PAEF) used for assessing expectation. The California Pharmacotherapy Alliance Scale (CALPAS), a measure associated with outcomes of antidepressant pharmacotherapy, was used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Scoring ranges from a minimum of 0 and a maximum of 120. The CALPAS score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A higher score indicates a positive outcome.
  • Change in HAMD Score [ Time Frame: Baseline,Week 8 ]
    Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Depressive symptoms; measured throughout the study
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Brain electrical activity; measured throughout the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
Official Title  ICMJE Factors of Treatment Response in Major Depressive Disorder
Brief Summary This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.
Detailed Description We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)
    Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
  • Other: Placebo
    Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
  • Behavioral: Interpersonal Clinical Interaction (ICI)
    Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
Study Arms  ICMJE
  • Active Comparator: MED

    For medication treatment, three different types were utilized and assigned specifically to each subject depending on their condition:

    MED 1: Venlafaxine XR. MED 2: Duloxetine (Cymbalta) MED 3: Escitalopram (Lexapro)

    Intervention: Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)
  • Placebo Comparator: Placebo (PBO)
    Subjects enrolled will receive interpersonal clinical interaction (ICI) along with a placebo treatment (Interaction and assessment as in ICI plus double blinded treatment with placebo tablets).
    Intervention: Other: Placebo
  • Interpersonal Clinical Interaction (ICI)
    Subjects assigned to the interpersonal clinical interaction (ICI) will undergo a one-week waiting period after the initial assessment. Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.
    Intervention: Behavioral: Interpersonal Clinical Interaction (ICI)
Publications * Leuchter AF, Hunter AM, Tartter M, Cook IA. Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression. Br J Psychiatry. 2014 Dec;205(6):443-9. doi: 10.1192/bjp.bp.113.140343. Epub 2014 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
88
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
120
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of unipolar major depression

Exclusion Criteria:

  • Substance abuse
  • Psychotic disorder
  • History of severe head trauma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200902
Other Study ID Numbers  ICMJE R01AT002479-02( U.S. NIH Grant/Contract )
R01AT002479-02 ( U.S. NIH Grant/Contract )
04-02-068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew F. Leuchter, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • Eli Lilly and Company
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Andrew F. Leuchter, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date March 2019

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