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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00375843
First received: September 12, 2006
Last updated: February 5, 2013
Last verified: September 2008
  Purpose

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 Intervention Phase
Depression
Drug: Escitalopram
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)"

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient acceptability of EEG measures [ Time Frame: Measured after final EEG recording ] [ Designated as safety issue: No ]
  • Relationship between brain physiologic measures and side effects [ Time Frame: Measured at study exit ] [ Designated as safety issue: No ]
  • Relationship between brain physiologic measures and quality of life measures [ Time Frame: Measured at study exit ] [ Designated as safety issue: No ]
  • Relationship between brain physiologic measures and psychosocial function measures [ Time Frame: Measured at study exit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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
Investigators
Principal Investigator: Ian Cook, MD UCLA Semel Institute
  More Information

Additional 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: R01 MH69217, DATR A5-ETMA, R01 MH069180 (Alpert)
Study First Received: September 12, 2006
Last Updated: February 5, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Sertraline
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 September 29, 2014