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

University of California, Los Angeles (UCLA) logo

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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