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Neurophysiologic Monitoring of Antidepressant Treatment (Lilly)

This study has been completed.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01360190
First received: May 23, 2011
Last updated: May 24, 2011
Last verified: May 2011
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360190

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

No publications provided

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
Study First Received: May 23, 2011
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Fluoxetine
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014