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

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Depression

Treatments: Behavioral: Interpersonal Clinical Interaction (ICI); Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro); Other: Placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00200902

R01AT002479-02 (U.S. NIH Grant/Contract)

04-02-068

Details and patient eligibility

About

This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.

Full description

We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of unipolar major depression

Exclusion criteria

• Substance abuse
• Psychotic disorder
• History of severe head trauma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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88 participants in 3 patient groups, including a placebo group

MED

Active Comparator group

Description:

For medication treatment, three different types were utilized and assigned specifically to each subject depending on their condition: MED 1: Venlafaxine XR. MED 2: Duloxetine (Cymbalta) MED 3: Escitalopram (Lexapro)

Treatment:

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

Placebo (PBO)

Placebo Comparator group

Description:

Subjects enrolled will receive interpersonal clinical interaction (ICI) along with a placebo treatment (Interaction and assessment as in ICI plus double blinded treatment with placebo tablets).

Treatment:

Other: Placebo

Interpersonal Clinical Interaction (ICI)

Other group

Description:

Subjects assigned to the interpersonal clinical interaction (ICI) will undergo a one-week waiting period after the initial assessment. Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.

Treatment:

Behavioral: Interpersonal Clinical Interaction (ICI)