Electroencephalography (EEG) Biomarkers of Response in Depression

NCT00759122 | Completed Phase 4

• 1 other identifier: Biomarkers in MDD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

There are two specific aims of this project:

1. 1.To identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine
2. 2.To identify predictors of placebo response in major depression using QEEG cordance/bispectral index (BIS) and neuropsychological testing

Conditions

Major Depressive Disorder

Keywords

mdd; major depressive disorder; depression

Study Arms (2)

1

ACTIVE COMPARATOR

VENLAFAXINE

Drug: venlafaxine (Effexor)

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

venlafaxine (Effexor) DRUG

Matching capsules containing venlafaxine 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.

1

placebo DRUG

Matching capsules containing placebo 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.

2

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Medtronic - MITG: collaborator
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

UCLA Laboratory of Brain, Behavior, and Pharmacology

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Ian A Cook, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: November 1, 2002
• Primary Completion: November 1, 2005
• Study Completion: December 1, 2005
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

US (1)