Electroencephalography (EEG) Biomarkers of Response in Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00759122
• Date of registration: 23/09/2008
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Electroencephalography (EEG) Biomarkers of Response in Depression
• Scientific title: EEG Biomarkers of Response in Depression
• Date of first enrolment: November 2002
• Target sample size: 44
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00759122
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ian A Cook, MD
• Affiliation: Professor

Key inclusion & exclusion criteria

Inclusion Criteria:

- All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P
interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2).

- Subjects will meet criteria both at recruitment and after a one-week single blind
placebo wash-in. Study includes outpatients only.

Exclusion Criteria:

- All subjects will have no serious medical illness. The investigators 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 from the study.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: placebo

Drug: venlafaxine (Effexor)

Secondary ID(s)

Biomarkers in MDD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Wyeth is now a wholly owned subsidiary of Pfizer

Covidien