Neuroimaging for Depression
Primary Purpose
Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-based problem solving therapy
Sponsored by

About this trial
This is an interventional diagnostic trial for Depression
Eligibility Criteria
Inclusion Criteria:
- DSM-IV criteria for minor or major depression
- Written informed consent
- Age 30-60 years (age of individuals currently in the astronaut corps)
Exclusion Criteria:
- 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Wait list
Computer-based problem solving therapy
Arm Description
Outcomes
Primary Outcome Measures
Functional magnetic resonance imaging
Secondary Outcome Measures
Functional near infrared neuroimaging
MRI-based brain perfusion
MRI-based brain morphology
MRI-based diffusion imaging
Full Information
NCT ID
NCT00864630
First Posted
March 17, 2009
Last Updated
May 23, 2011
Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center, Emory University
1. Study Identification
Unique Protocol Identification Number
NCT00864630
Brief Title
Neuroimaging for Depression
Official Title
Objective Detection, Evaluation and Countermeasures for In-flight Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
The study upon which this project depended for subjects and the intervention was terminated prematurely due to lack of funds.
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Beth Israel Deaconess Medical Center, Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Depression can significantly disrupt one's ability to function effectively and efficiently, and the associated performance deficits can seriously jeopardize space mission success. The incidence of serious depression in Earth based analogues of the spaceflight environment has been reported as up to 13% per person per year. Extrapolating from existing reports of depressive episodes during short-duration spaceflight, depression is thus a probable condition in one or more members of a five to seven person crew during a long duration spaceflight (e.g., a 30 month mission to Mars). Mission success can be jeopardized by depression either directly, from the potentially life threatening consequences of lapses in performance, or indirectly, by adding to the workload and stress of other crewmembers. The likelihood and potentially serious consequences of depression during spaceflight explains why the risk of human performance failure due to mood alterations such as depression, anxiety, or other psychiatric and cognitive problems is a Priority 1 risk for all mission types (International Space Station, Moon, Mars). Certain countermeasures are already in place: medications and psychological consultations with ground-crews. However, current in-flight methods to decide whether a countermeasure should be used rely heavily on subjective self-reports. The biological basis of mood disorders suggests neural biomarkers may provide a more objective method for assessing depression. Aim 1 of this proposal, therefore, seeks to identify neural biomarkers sensitive to, and specific for, depression. These measures will be used in evaluating and validating a flight-capable, noninvasive neuroimaging technology (near-infrared spectroscopy and imaging, or NIRS imaging) for its ability to detect biomarkers of depression and its severity. As an initial step towards developing novel select-out criteria, Aim 2 will then evaluate which neural biomarkers appear most promising in detecting an endophenotype that identifies individuals at heightened risk for treatment resistance. Finally, when depression is objectively identified, an appropriate countermeasure needs to be selected. Aim 3 will focus on the ability of brain imaging to help predict the efficacy of Dr. Cartriene's computer based problem solving therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wait list
Arm Type
No Intervention
Arm Title
Computer-based problem solving therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Computer-based problem solving therapy
Intervention Description
Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.
Primary Outcome Measure Information:
Title
Functional magnetic resonance imaging
Time Frame
Pre-therapy and 4 weeks after therapy initiation
Secondary Outcome Measure Information:
Title
Functional near infrared neuroimaging
Time Frame
Pre-therapy and 2 and 4 weeks after therapy initiation
Title
MRI-based brain perfusion
Time Frame
Pre-therapy and 4 weeks after therapy initiation
Title
MRI-based brain morphology
Time Frame
Pre-therapy and 4 weeks after therapy initiation
Title
MRI-based diffusion imaging
Time Frame
Pre-therapy and 4 weeks after therapy initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV criteria for minor or major depression
Written informed consent
Age 30-60 years (age of individuals currently in the astronaut corps)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary E Strangman, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
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Neuroimaging for Depression
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