search
Back to results

Study of Medication and Placebo Response in Major Depression

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sertraline (Zoloft)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression, EEG, QEEG, cordance, Zoloft, sertraline, placebo, electroencephalogram, brain, antidepressants

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical Diagnosis of Unipolar Major Depression Exclusion Criteria: Substance Abuse, Psychotic Disorder, History of Severe Head Trauma

Sites / Locations

  • UCLA Neuropsychiatric Institute & Hospital

Outcomes

Primary Outcome Measures

depressive symptoms

Secondary Outcome Measures

brain electrical activity (EEG)

Full Information

First Posted
September 28, 2005
Last Updated
November 3, 2016
Sponsor
University of California, Los Angeles
Collaborators
Eli Lilly and Company, Pfizer, Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00229476
Brief Title
Study of Medication and Placebo Response in Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles
Collaborators
Eli Lilly and Company, Pfizer, Massachusetts General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depression, EEG, QEEG, cordance, Zoloft, sertraline, placebo, electroencephalogram, brain, antidepressants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sertraline (Zoloft)
Primary Outcome Measure Information:
Title
depressive symptoms
Secondary Outcome Measure Information:
Title
brain electrical activity (EEG)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Diagnosis of Unipolar Major Depression Exclusion Criteria: Substance Abuse, Psychotic Disorder, History of Severe Head Trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew F. Leuchter, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Neuropsychiatric Institute & Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11772700
Citation
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. doi: 10.1176/appi.ajp.159.1.122.
Results Reference
background
PubMed Identifier
12062912
Citation
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. doi: 10.1016/S0893-133X(02)00294-4.
Results Reference
background
PubMed Identifier
15252704
Citation
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. doi: 10.1007/s00213-004-1919-2. Epub 2004 Jul 14.
Results Reference
background
Links:
URL
http://www.DepressionResearch.com/
Description
Depression Research at UCLA - Click here for more information about this study: Study of Medication and Placebo Response in Major Depression

Learn more about this trial

Study of Medication and Placebo Response in Major Depression

We'll reach out to this number within 24 hrs