Study Stopped
The study upon which this project depended for subjects and the intervention was terminated prematurely due to lack of funds.
Neuroimaging for Depression
Objective Detection, Evaluation and Countermeasures for In-flight Depression
1 other identifier
interventional
68
1 country
1
Brief Summary
The investigators seek to determine whether brain imaging techniques can be used to help detect depression, assess its severity, and/or monitor or predict responses to treatment. Subjects with minor or major depression will be randomly assigned to a wait-list control group or to treatment with a new computer-based cognitive behavior therapy developed by Dr. James Cartriene. Brain imaging will be performed before and during treatment using both magnetic resonance imaging (MRI) and near-infrared spectroscopy (NIRS). The investigators hypothesize that brain activity, particularly in the lateral frontal areas of the brain, will provide biomarkers for depression, depression severity, and treatment response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 24, 2011
May 1, 2011
1.1 years
March 17, 2009
May 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Functional magnetic resonance imaging
Pre-therapy and 4 weeks after therapy initiation
Secondary Outcomes (4)
Functional near infrared neuroimaging
Pre-therapy and 2 and 4 weeks after therapy initiation
MRI-based brain perfusion
Pre-therapy and 4 weeks after therapy initiation
MRI-based brain morphology
Pre-therapy and 4 weeks after therapy initiation
MRI-based diffusion imaging
Pre-therapy and 4 weeks after therapy initiation
Study Arms (2)
Wait list
NO INTERVENTIONComputer-based problem solving therapy
EXPERIMENTALInterventions
Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.
Eligibility Criteria
You may qualify if:
- DSM-IV criteria for minor or major depression
- Written informed consent
- Age 30-60 years (age of individuals currently in the astronaut corps)
You may not qualify if:
- Suicidal or homicidal ideation
- Women who are pregnant, breastfeeding, or women of childbearing potential who are not using a medically accepted means of contraception
- Known history of serious or unstable medical illness
- History of seizure disorder, brain injury, any history of known neurological disease
- Clinical or lab evidence of untreated hypothyroidism
- History or DSM-IV diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance use disorders (excluding alcohol and nicotine) active within the last 12 months
- Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants
- Patients who have failed to respond during the course of their current major depressive episode to at least two antidepressant trials
- Currently undergoing depression-focused psychotherapy
- Patients who have taken an investigational psychotropic drug within the past year
- Patient cannot safely enter the MRI scanning environment
- Latex allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Beth Israel Deaconess Medical Centercollaborator
- Emory Universitycollaborator
Study Sites (1)
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary E Strangman, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 17, 2009
First Posted
March 19, 2009
Study Start
September 1, 2010
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
May 24, 2011
Record last verified: 2011-05