- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200902
Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
July 26, 2021 updated by: Andrew F. Leuchter, University of California, Los Angeles
Factors of Treatment Response in Major Depressive Disorder
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90024
- UCLA Laboratory of Brain, Behavior, and Pharmacology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of unipolar major depression
Exclusion Criteria:
- Substance abuse
- Psychotic disorder
- History of severe head trauma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MED
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) |
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.
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Placebo Comparator: Placebo (PBO)
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).
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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: 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.
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Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response as Assessed by Participants' Change in Depression Rating
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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Average Change in 3 Weeks of Participant Treatment Expectations
Time Frame: Averaged over 3 time points (Baseline, randomization, and end of lead-in)
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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.
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Averaged over 3 time points (Baseline, randomization, and end of lead-in)
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Change in Hamilton Depression Assessment Score
Time Frame: Baseline,Week 8
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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.
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Baseline,Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew F. Leuchter, MD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
- Citalopram
- Venlafaxine Hydrochloride
Other Study ID Numbers
- R01AT002479-02 (U.S. NIH Grant/Contract)
- 04-02-068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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