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

Depression Clinical Trial

Official title:

Factors of Treatment Response in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200902
• Other study ID #: R01AT002479-02
• Secondary ID: R01AT002479-0204
• Status: Completed
• Phase: Phase 4
• Start date: August 2005
• Est. completion date: June 2009

Study information

• Verified date: July 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of unipolar major depression

Exclusion Criteria:

• Substance abuse

• Psychotic disorder

• History of severe head trauma

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Laboratory of Brain, Behavior, and Pharmacology	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Los Angeles	Eli Lilly and Company, National Center for Complementary and Integrative Health (NCCIH), Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response as Assessed by Participants' Change in Depression Rating	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.	Baseline, Week 8
Primary	Average Change in 3 Weeks of Participant Treatment Expectations	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.	Averaged over 3 time points (Baseline, randomization, and end of lead-in)
Primary	Change in Hamilton Depression Assessment Score	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.	Baseline,Week 8

External Links

•   Depression Research - Click here for more information about this study: Psychobiologic Factors of the Placebo Response in MDD