Neurophysiologic Monitoring of Antidepressant Treatment

NCT01360190 | Completed Phase 4

• 1 other identifier: 94-08-273-13
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

MDD; major depressive disorder; QEEG; electroencephalograph; fluoxtine; placebo

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Rating Scale For Depression Score

  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).

  baseline, end of placebo-lead-in; and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment

Study Arms (2)

fluoxetine

ACTIVE COMPARATOR

Drug: fluoxetine

placebo

PLACEBO COMPARATOR

Drug: fluoxetine

Interventions

fluoxetine DRUG

fluoxetine 20 mg. daily

fluoxetine; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Andrew F Leuchter

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: May 25, 2011
• Study Start: August 1, 1994
• Primary Completion: August 1, 1996
• Study Completion: August 1, 1996
• Last Updated: May 25, 2011

Record last verified: 2011-05