Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression

PHASE4CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Depression
Interventions
DRUG

Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)

Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.

OTHER

Placebo

Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.

BEHAVIORAL

Interpersonal Clinical Interaction (ICI)

Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.

Trial Locations (1)

90024

UCLA Laboratory of Brain, Behavior, and Pharmacology, Los Angeles

All Listed Sponsors
collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

collaborator

Eli Lilly and Company

INDUSTRY

collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

lead

University of California, Los Angeles

OTHER

NCT00200902 - Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression | Biotech Hunter | Biotech Hunter