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NCT00229476 Clinical Trial

Study of Medication and Placebo Response in Major Depression

Depressive Disorder, Major Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00229476
Other study ID # 03-08-033
Secondary ID H6U-US-X00204012
Status Completed
Phase Phase 4
First received September 28, 2005
Last updated November 3, 2016
Start date December 2003

Study information
Verified date November 2016
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Clinical Diagnosis of Unipolar Major Depression

Exclusion Criteria:

- Substance Abuse, Psychotic Disorder, History of Severe Head Trauma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• sertraline (Zoloft)

Locations
Country Name City State
United States UCLA Neuropsychiatric Institute & Hospital Los Angeles California

Sponsors (4)
Lead Sponsor Collaborator
University of California, Los Angeles Eli Lilly and Company, Massachusetts General Hospital, Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary depressive symptoms
Secondary brain electrical activity (EEG)
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