We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication

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: NCT00375843
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : February 6, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression.

Condition or disease Intervention/treatment Phase
Depression Drug: Escitalopram Drug: Sertraline Phase 4

Detailed Description:

Depression is a serious medical illness that is characterized by a persistent sad, anxious, or empty mood. Many treatments have been shown to relieve depression, including both medications and behavioral therapies. No single treatment, however, works for everyone. Approximately half of the people being treated for depression do not respond to the first medication they try. Studies have shown that some people with depression show changes in brain activity within 2 weeks of starting treatment, even though symptoms do not change until later. People who do not respond to treatment, however, do not exhibit these changes in brain activity. More information is needed to understand the different ways in which people with depression respond to medication. This study will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression. It will also determine whether the brain testing involved in this study is burdensome to the participants.

Individuals interested in taking part in this 1-year study will first attend one screening visit to determine their eligibility for participation. Before beginning treatment, all participants will have an electroencephalogram (EEG) to determine baseline brain activity. Participants will then receive up to 12 weeks of treatment with escitalopram, an antidepressant medication. Study visits will be held every 2 to 3 weeks during this phase. At the Week 2 visit, participants will have another EEG. Participants who respond to escitalopram by the end of the treatment phase will be asked to participate in a 6-month follow-up phase, in which participants will be followed by their own personal physicians, but will have the option to continue treatment with escitalopram. Follow-up visits will be held at Months 3 and 6. Participants who do not respond to escitalopram by the end of the treatment phase will have another EEG, and will then receive up to 12 weeks of treatment with sertraline, another antidepressant medication. Study visits will be held every 2 to 3 weeks, and participants will have a fourth EEG at Week 2. Participants who respond to sertraline will then enter the 6-month follow-up phase, and may continue receiving sertraline. Participants who do not improve with sertraline will receive referrals for additional care outside of the study.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Response Variability in Treatment Resistant Depression - an Ancillary Study to "Sequenced Treatment Alternatives to Relieve Depression (STAR*D)"
Study Start Date : January 2005
Primary Completion Date : June 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Level 1 Treatment: Escitalopram
Level 1 participants who are assigned to escitalopram
Drug: Escitalopram
Level 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks.
Other Name: Lexapro
Active Comparator: Level 2: Sertraline
Participants from Level 1 who do not achieve remission with escitalopram enter Level 2 and switch to sertraline
Drug: Sertraline
Level 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks.
Other Name: Zoloft


Outcome Measures

Primary Outcome Measures :
  1. Relationship between depression symptoms and brain physiologic measures [ Time Frame: Measured at exit from Level 1 treatment or from Level 2 treatment (each 12 weeks duration) ]

Secondary Outcome Measures :
  1. Patient acceptability of EEG measures [ Time Frame: Measured after final EEG recording ]
  2. Relationship between brain physiologic measures and side effects [ Time Frame: Measured at study exit ]
  3. Relationship between brain physiologic measures and quality of life measures [ Time Frame: Measured at study exit ]
  4. Relationship between brain physiologic measures and psychosocial function measures [ Time Frame: Measured at study exit ]
  5. Relationship between brain physiologic measures and durability of remission, assessed as return of depressive symptoms during the 6 month follow-on phase [ Time Frame: Measured at Month 6 of follow-on phase ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently an outpatient with nonpsychotic, unipolar major depressive disorder (MDD)
  • Score of 14 or greater on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
  • Antidepressant treatment is deemed appropriate by the study clinician
  • Willing to use an effective form of contraception throughout the study

Exclusion Criteria:

  • Mentally or legally incapacitated
  • Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, MDD with psychotic features, or dementia
  • Patients currently suffering from anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder
  • History of substance abuse disorder within 6 months prior to study entry
  • Current suicidal ideation that would make outpatient treatment unsafe
  • Past medication response that may make escitalopram or sertraline treatment unsafe or inappropriate (e.g., previous intolerance or lack of response to either medication)
  • History of a failed treatment with escitalopram (40 mg or more) or sertraline (200 mg or more) during the current depressive episode
  • Any medical conditions that would make treatment with escitalopram or sertraline medically inadvisable
  • Unstable medical illness
  • Unstable psychiatric illness likely to require inpatient treatment within the 6 months following study entry
  • History of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal EEG
  • Pregnant or plans to become pregnant within the 12 months following study entry
  • Breastfeeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375843


Locations
United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Massachusetts
Harvard/MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Ian Cook, MD UCLA Semel Institute
More Information

Publications:
Responsible Party: Ian A. Cook, MD, PI, University of California, Los Angelos
ClinicalTrials.gov Identifier: NCT00375843     History of Changes
Other Study ID Numbers: R01MH069217 ( U.S. NIH Grant/Contract )
DATR A5-ETMA
R01 MH069180 (Alpert)
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: September 2008

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Sertraline
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents