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Study of Medication and Placebo Response in Major Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00229476
First Posted: September 29, 2005
Last Update Posted: November 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eli Lilly and Company
Pfizer
Massachusetts General Hospital
Information provided by:
University of California, Los Angeles
  Purpose
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.

Condition Intervention Phase
Depressive Disorder, Major Drug: sertraline (Zoloft) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • depressive symptoms

Secondary Outcome Measures:
  • brain electrical activity (EEG)

Estimated Enrollment: 60
Study Start Date: December 2003
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical Diagnosis of Unipolar Major Depression

Exclusion Criteria:

  • Substance Abuse, Psychotic Disorder, History of Severe Head Trauma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229476


Locations
United States, California
UCLA Neuropsychiatric Institute & Hospital
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Eli Lilly and Company
Pfizer
Massachusetts General Hospital
Investigators
Principal Investigator: Andrew F. Leuchter, M.D. University of California, Los Angeles
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00229476     History of Changes
Other Study ID Numbers: 03-08-033
H6U-US-X002
04012549
First Submitted: September 28, 2005
First Posted: September 29, 2005
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by University of California, Los Angeles:
Depression
EEG
QEEG
cordance
Zoloft
sertraline
placebo
electroencephalogram
brain
antidepressants

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs