NCT00229476

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

September 28, 2005

Last Update Submit

November 3, 2016

Conditions

Depressive Disorder, Major

Keywords

DepressionEEGQEEGcordanceZoloftsertralineplaceboelectroencephalogrambrainantidepressants

Outcome Measures

Primary Outcomes (1)

  • depressive symptoms

Secondary Outcomes (1)

  • brain electrical activity (EEG)

Interventions

sertraline (Zoloft)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of Unipolar Major Depression

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Neuropsychiatric Institute & Hospital

Los Angeles, California, 90024, United States

Location

Related Publications (3)

  • 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.

    PMID: 11772700BACKGROUND

  • 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.

    PMID: 12062912BACKGROUND

  • 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.

    PMID: 15252704BACKGROUND

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Andrew F. Leuchter, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 29, 2005

Study Start

December 1, 2003

Primary Completion

March 1, 2006

Last Updated

November 7, 2016

Record last verified: 2016-11

Locations

US(1)