Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication
Response Variability in Treatment Resistant Depression - an Ancillary Study to "Sequenced Treatment Alternatives to Relieve Depression (STAR*D)"
3 other identifiers
interventional
118
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 depression
Started Jan 2005
Typical duration for phase_4 depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2006
CompletedFirst Posted
Study publicly available on registry
September 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFebruary 6, 2013
September 1, 2008
2.4 years
September 12, 2006
February 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Relationship between depression symptoms and brain physiologic measures
Measured at exit from Level 1 treatment or from Level 2 treatment (each 12 weeks duration)
Secondary Outcomes (5)
Patient acceptability of EEG measures
Measured after final EEG recording
Relationship between brain physiologic measures and side effects
Measured at study exit
Relationship between brain physiologic measures and quality of life measures
Measured at study exit
Relationship between brain physiologic measures and psychosocial function measures
Measured at study exit
Relationship between brain physiologic measures and durability of remission, assessed as return of depressive symptoms during the 6 month follow-on phase
Measured at Month 6 of follow-on phase
Study Arms (2)
Level 1 Treatment: Escitalopram
ACTIVE COMPARATORLevel 1 participants who are assigned to escitalopram
Level 2: Sertraline
ACTIVE COMPARATORParticipants from Level 1 who do not achieve remission with escitalopram enter Level 2 and switch to sertraline
Interventions
Level 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks.
Level 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UCLA Semel Institute
Los Angeles, California, 90095, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Harvard/MGH
Boston, Massachusetts, 02114, United States
Related Publications (2)
Leuchter AF, Cook IA, Witte EA, Morgan M, Abrams M. Changes in brain function of depressed subjects during treatment with placebo. Am J Psychiatry. 2002 Jan;159(1):122-9. doi: 10.1176/appi.ajp.159.1.122.
PMID: 11772700BACKGROUNDCook IA, Leuchter AF, Morgan M, Witte E, Stubbeman WF, Abrams M, Rosenberg S, Uijtdehaage SH. Early changes in prefrontal activity characterize clinical responders to antidepressants. Neuropsychopharmacology. 2002 Jul;27(1):120-31. doi: 10.1016/S0893-133X(02)00294-4.
PMID: 12062912BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Cook, MD
UCLA Semel Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 12, 2006
First Posted
September 13, 2006
Study Start
January 1, 2005
Primary Completion
June 1, 2007
Study Completion
March 1, 2008
Last Updated
February 6, 2013
Record last verified: 2008-09