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

Phase 4

Completed

• Conditions: Depression
• Interventions: Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro); Behavioral: Interpersonal Clinical Interaction (ICI); Other: Placebo

• Registration Number: NCT00200902
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2018-05-25
• Results First Submitted QC: 2019-03-21
• Results First Posted: 2019-04-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Clinical diagnosis of unipolar major depression

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MED	Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)	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)
Interpersonal Clinical Interaction (ICI)	Interpersonal Clinical Interaction (ICI)	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.
Placebo (PBO)	Placebo	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).

Primary Outcome Measures

Name	Time	Method
Average Change in 3 Weeks of Participant Treatment Expectations	Averaged over 3 time points (Baseline, randomization, and end of lead-in)	Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome.
Change in Hamilton Depression Assessment Score	Baseline,Week 8	Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.
Response as Assessed by Participants' Change in Depression Rating	Baseline, Week 8	Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.

Trial Locations

Locations (1)

UCLA Laboratory of Brain, Behavior, and Pharmacology; 🇺🇸 Los Angeles, California, United States