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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00200902
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Eli Lilly and Company
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Andrew F. Leuchter, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)
Other: Placebo
Behavioral: Interpersonal Clinical Interaction (ICI)
Enrollment 88
Recruitment Details 133 subjects were screened for eligibility and 88 were eligible for enrollment between 8/19/05 - 8/7/08 at the UCLA Laboratory of Brain, Behavior, and Pharmacology. 88 participants were randomized however, n=67 for many of the measures as subjects who did not complete the Week 8 visit were not included in the analysis.
Pre-assignment Details Subjects were required to wash out of any other antidepressant medications for one week (30 days if washing out from fluoxetine).
Arm/Group Title MEDS + ICI Placebo+ICI ICI Alone
Hide Arm/Group Description MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro) [Not Specified] Subjects assigned to the interpersonal clinical interaction (ICI). 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.
Period Title: Overall Study
Started [1] 39 29 20
Completed 29 26 12
Not Completed 10 3 8
[1]
Overall for this study, n=67 assessed for many measures in Results section.
Arm/Group Title Medication Treatment (MED) Placebo Interpersonal Clinical Interaction Total
Hide Arm/Group Description MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro) [Not Specified] Subjects assigned to the interpersonal clinical interaction (ICI). Visits 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. Total of all reporting groups
Overall Number of Baseline Participants 39 29 20 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 29 participants 20 participants 88 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
29
 100.0%
20
 100.0%
88
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 29 participants 20 participants 88 participants
41.67  (13.63) 41.75  (14.35) 43.1  (12.7) 41.96  (13.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 29 participants 20 participants 88 participants
Female
25
  64.1%
18
  62.1%
12
  60.0%
55
  62.5%
Male
14
  35.9%
11
  37.9%
8
  40.0%
33
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 29 participants 20 participants 88 participants
29 26 12 67
1.Primary Outcome
Title Response as Assessed by Participants' Change in Depression Rating
Hide Description 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.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the Week 8 visit were included in the analysis (n=67)
Arm/Group Title MEDICATIONS Placebo (PBO) Interpersonal Clinical Interaction (ICI)
Hide Arm/Group Description:
Three different types of medications were utilized and assigned specifically to each subject depending on their condition. Interpersonal clinical interaction (ICI) plus clinically assigned medication (Venlafaxine XR, Duloxetine, or Escitalopram).
Interpersonal clinical interaction (ICI) plus placebo
Interpersonal clinical interaction (ICI) ONLY
Overall Number of Participants Analyzed 29 26 12
Measure Type: Count of Participants
Unit of Measure: Participants
Responders
17
  58.6%
11
  42.3%
1
   8.3%
Remitters
9
  31.0%
9
  34.6%
0
   0.0%
2.Primary Outcome
Title Average Change in 3 Weeks of Participant Treatment Expectations
Hide Description Patient Attitudes and Expectations Form PAEF) used for assessing expectation. The California Pharmacotherapy Alliance Scale (CALPAS), a measure associated with outcomes of antidepressant pharmacotherapy, was 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). Scoring ranges from a minimum of 0 and a maximum of 120. The CALPAS 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 higher score indicates a positive outcome.
Time Frame Averaged over 3 time points (Baseline, randomization, and end of lead-in)
Hide Outcome Measure Data
Hide Analysis Population Description
88 participants who completed the first 3 time points in the study
Arm/Group Title Medication (MED) Placebo (PBO) Interpersonal Clinical Interaction (ICI)
Hide Arm/Group Description:
MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)

Placebo subjects received interpersonal clinical interaction (ICI) along with placebo treatment.

Placebo: Subjects assigned to the placebo (PBO) or medication (MED) condition entered double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They underwent the same schedule, structure, and intensity of visits as in the ICI condition, but also were randomized to receive treatment with a pill. Subjects randomized to medication 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.

Interpersonal Clinical Interaction (ICI) ONLY
Overall Number of Participants Analyzed 39 29 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.55  (.78) 3.94  (.61) 3.17  (1.16)
3.Primary Outcome
Title Change in HAMD Score
Hide Description 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.
Time Frame Baseline,Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medication (MED) Placebo (PBO) Interpersonal Clinical Interaction (ICI)
Hide Arm/Group Description:
Venlafaxine (Effexor), Duloxetine (Cymbalta), or Escitalopram (Lexapro) + ICI
Placebo + ICI
ICI ONLY
Overall Number of Participants Analyzed 29 26 12
Mean (Standard Deviation)
Unit of Measure: HAMD score
Percent Change in HAM-D -0.46  (0.31) -0.36  (0.39) -0.05  (0.27)
Change in HAM-D -10.05  (6.60) -7.59  (7.98) -1.37  (5.27)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medication Placebo (PBO) Interpersonal Clinical Interaction (ICI)
Hide Arm/Group Description Venlafaxine (Effexor), Duloxetine (Cymbalta), or Escitalopram (Lexapro) + ICI Placebo + ICI ICI ONLY
All-Cause Mortality
Medication Placebo (PBO) Interpersonal Clinical Interaction (ICI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Medication Placebo (PBO) Interpersonal Clinical Interaction (ICI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/29 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medication Placebo (PBO) Interpersonal Clinical Interaction (ICI)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/26 (0.00%)   0/12 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Leuchter, MD
Organization: Laboratory of Brain, Behavior, and Pharmacology at the University of California Los Angeles
Phone: 310-825-0207
EMail: jpv@brain.ucla.edu
Layout table for additonal information
Responsible Party: Andrew F. Leuchter, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00200902    
Other Study ID Numbers: R01AT002479-02 ( U.S. NIH Grant/Contract )
R01AT002479-02 ( U.S. NIH Grant/Contract )
04-02-068
First Submitted: September 14, 2005
First Posted: September 20, 2005
Results First Submitted: May 25, 2018
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019