MedDataX Logo

Study of Medication and Placebo Response in Major Depression

NCT ID: NCT00229476

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder, Major

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression EEG QEEG cordance Zoloft sertraline placebo electroencephalogram brain antidepressants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sertraline (Zoloft)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical Diagnosis of Unipolar Major Depression

Exclusion Criteria

* Substance Abuse, Psychotic Disorder, History of Severe Head Trauma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew F. Leuchter, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCLA Neuropsychiatric Institute & Hospital

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11772700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12062912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15252704 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.DepressionResearch.com/

Depression Research at UCLA - Click here for more information about this study: Study of Medication and Placebo Response in Major Depression

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H6U-US-X002

Identifier Type: -

Identifier Source: secondary_id

04012549

Identifier Type: -

Identifier Source: secondary_id

03-08-033

Identifier Type: -

Identifier Source: org_study_id