Study of Medication and Placebo Response in Major Depression

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Pfizer
Massachusetts General Hospital
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00229476
First received: September 28, 2005
Last updated: April 20, 2007
Last verified: April 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00229476     History of Changes
Other Study ID Numbers: 03-08-033, H6U-US-X002, 04012549
Study First Received: September 28, 2005
Last Updated: April 20, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014