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

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Eli Lilly and Company
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00200902
First received: September 14, 2005
Last updated: November 19, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Depression
Drug: venlafaxine (Effexor)
Drug: duloxetine (Cymbalta)
Drug: escitalopram (Lexapro)
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Factors of Treatment Response in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Depressive symptoms; measured throughout the study [ Time Frame: Baseline visit, end-of-lead in, 48 hour post tx assignment, week 1, week 2, week 4, week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brain electrical activity; measured throughout the study [ Time Frame: Baseline visit, end-of-lead in, 48 hour post tx assignment, week 1, week 2, week 4, week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2005
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
venlafaxine XR
Drug: venlafaxine (Effexor)
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.
Active Comparator: 2
duloxetine (Cymbalta)
Drug: duloxetine (Cymbalta)
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.
Active Comparator: 3
escitalopram (Lexapro)
Drug: 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.
Placebo Comparator: placebo 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.
No Intervention: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of unipolar major depression

Exclusion Criteria:

  • Substance abuse
  • Psychotic disorder
  • History of severe head trauma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200902

Locations
United States, California
UCLA Laboratory of Brain, Behavior, and Pharmacology
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Eli Lilly and Company
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Andrew F. Leuchter, MD University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Andrew F. Leuchter, MD, University of California Los Angeles
ClinicalTrials.gov Identifier: NCT00200902     History of Changes
Other Study ID Numbers: R01 AT002479-02, R01AT002479-02, 04-02-068
Study First Received: September 14, 2005
Last Updated: November 19, 2009
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Major depressive disorder
MDD
Antidepressant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Venlafaxine
Duloxetine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014