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Neurophysiologic Monitoring of Antidepressant Treatment (Lilly)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01360190
First Posted: May 25, 2011
Last Update Posted: May 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Los Angeles
  Purpose
The overall goal of this proposal is to study quantitative electroencephalography (QEEG ) as a method for the detection of antidepressant treatment response. The investigators have developed a QEEG algorithm called "cordance" that appears to provide much the same information about brain function as PET or SPECT scanning, and has shown patterns of brain function that appear to be indicative of depression. Of greatest interest is that these patterns appear to normalize in response to antidepressant treatment.

Condition Intervention Phase
Major Depressive Disorder Drug: fluoxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neurophysiologic Monitoring of Antidepressant Treatment

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in Hamilton Rating Scale For Depression Score [ Time Frame: baseline, end of placebo-lead-in; and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment ]
    We will determine which subjects demonstrate improvement on the primary outcome measure (Ham-D) obtained the day of the EEG, and enter these as categorical variables (improved/not improved).


Enrollment: 24
Study Start Date: August 1994
Study Completion Date: August 1996
Primary Completion Date: August 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fluoxetine Drug: fluoxetine
fluoxetine 20 mg. daily
Placebo Comparator: placebo Drug: fluoxetine
fluoxetine 20 mg. daily

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects will meet DSM-IV criteria for major depression based upon the Structured Clinical Interview for DSM-IV - Patient Version (SCID-P) (First et al., 1994). All research personnel have undergone SCID-P training, and soon will extend this training to the DSM-IV version.
  • Subjects also will have a score on the 17-item Hamilton Depression Rating Scale of > 18 (with item #1 > 2).
  • All subjects will be under the care of a clinician not affiliated with the study at the time of entry into the study, and through the course of the study.

Exclusion Criteria:

  • Subjects will have no serious medical illness.
  • We will exclude patients also meeting criteria for the following groups of axis I diagnoses: delirium or dementia, substance-related disorders, schizophrenia or other psychotic disorders, or eating disorders.
  • In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded.
  • Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded, as will patients who previously have failed to respond to an adequate clinical trial of fluoxetine, or have failed to tolerate the medication.
  • Subjects who have had suboptimal trials, however, may still be considered for the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360190


Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Andrew F Leuchter University of California, Los Angeles
  More Information

Responsible Party: Andrew F. Leuchter, MD, UCLA Laboratory of Brain, Behavior, and Pharmacology
ClinicalTrials.gov Identifier: NCT01360190     History of Changes
Other Study ID Numbers: 94-08-273-13
First Submitted: May 23, 2011
First Posted: May 25, 2011
Last Update Posted: May 25, 2011
Last Verified: May 2011

Keywords provided by University of California, Los Angeles:
MDD
major depressive disorder
QEEG
electroencephalograph
fluoxtine
placebo

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors