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Trial record 1 of 1 for:    NCT00229476
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Study of Medication and Placebo Response in Major Depression

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ClinicalTrials.gov Identifier: NCT00229476
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : November 6, 2016
Sponsor:
Collaborators:
Eli Lilly and Company
Pfizer
Massachusetts General Hospital
Information provided by:
University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE September 28, 2005
First Posted Date  ICMJE September 29, 2005
Last Update Posted Date November 6, 2016
Study Start Date  ICMJE December 2003
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
depressive symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
brain electrical activity (EEG)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Medication and Placebo Response in Major Depression
Official Title  ICMJE Not Provided
Brief Summary The primary purpose of the research study is to use recordings of brain electrical activity (through electroencephalogram, or EEG) and symptom measurements to determine whether patients are likely to show a response to medication or placebo treatment during a treatment trial for depression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE Drug: sertraline (Zoloft)
Study Arms  ICMJE Not Provided
Publications *

*   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
Enrollment  ICMJE
 (submitted: September 28, 2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2006   (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 NCT00229476
Other Study ID Numbers  ICMJE 03-08-033
H6U-US-X002
04012549
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • Eli Lilly and Company
  • Pfizer
  • Massachusetts General Hospital
Investigators  ICMJE
Principal Investigator: Andrew F. Leuchter, M.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date November 2016

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