Study of Medication and Placebo Response in Major Depression

This study has been completed.

First Received on September 28, 2005. Last Updated on April 20, 2007 History of Changes

Sponsor:	University of California, Los Angeles
Collaborators:	Eli Lilly and Company Pfizer Massachusetts General Hospital
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00229476

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 IV

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:

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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

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:

Depression Research at UCLA - Click here for more information about this study: Study of Medication and Placebo Response in Major Depression This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Leuchter AF, Cook IA, Witte EA, Morgan M, Abrams M. Changes in brain function of depressed subjects during treatment with placebo. Am J Psychiatry. 2002 Jan;159(1):122-9.

Cook IA, Leuchter AF, Morgan M, Witte E, Stubbeman WF, Abrams M, Rosenberg S, Uijtdehaage SH. Early changes in prefrontal activity characterize clinical responders to antidepressants. Neuropsychopharmacology. 2002 Jul;27(1):120-31.

Leuchter AF, Morgan M, Cook IA, Dunkin J, Abrams M, Witte E. Pretreatment neurophysiological and clinical characteristics of placebo responders in treatment trials for major depression. Psychopharmacology (Berl). 2004 Dec;177(1-2):15-22. Epub 2004 Jul 14.

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 February 09, 2012