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

NCT00200902 | Completed Phase 4 Results DMC

• 2 other identifiers: R01AT002479-0204-02-068
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Major depressive disorder; MDD; Antidepressant

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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

Study Arms (3)

MED

ACTIVE COMPARATOR

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)

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

Placebo (PBO)

PLACEBO COMPARATOR

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).

Other: Placebo

Interpersonal Clinical Interaction (ICI)

OTHER

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.

Behavioral: Interpersonal Clinical Interaction (ICI)

Interventions

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

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.

MED

Placebo OTHER

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.

Placebo (PBO)

Interpersonal Clinical Interaction (ICI) BEHAVIORAL

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

Interpersonal Clinical Interaction (ICI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of unipolar major depression

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Eli Lilly and Company: collaborator
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

UCLA Laboratory of Brain, Behavior, and Pharmacology

Los Angeles, California, 90024, United States

Location

Related Publications (1)

• Leuchter AF, Hunter AM, Tartter M, Cook IA. Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression. Br J Psychiatry. 2014 Dec;205(6):443-9. doi: 10.1192/bjp.bp.113.140343. Epub 2014 Sep 11.

  PMID: 25213159 DERIVED

Related Links

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

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Venlafaxine Hydrochloride; Duloxetine Hydrochloride; Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Individuals entering this study were aware that they might be assigned to a treatment condition that did not involve the use of medication; it is not certain that they are representative of people with MDD who would enter clinical trials for MDD.

Results Point of Contact

• Title: Andrew Leuchter, MD
• Organization: Laboratory of Brain, Behavior, and Pharmacology at the University of California Los Angeles

jpv@brain.ucla.edu

310-825-0207

Study Officials

• Andrew F. Leuchter, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 13, 2024
• Results First Posted: April 10, 2019

Record last verified: 2024-08

Locations

US (1)