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Neuroimaging for Depression

Objective Detection, Evaluation and Countermeasures for In-flight Depression

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00864630
Enrollment
68
Registered
2009-03-19
Start date
2010-09-30
Completion date
2011-12-31
Last updated
2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

BEHAVIORALComputer-based problem solving therapy

Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.

Sponsors

Beth Israel Deaconess Medical Center
CollaboratorOTHER
Emory University
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Functional magnetic resonance imagingPre-therapy and 4 weeks after therapy initiation

Secondary

MeasureTime frame
Functional near infrared neuroimagingPre-therapy and 2 and 4 weeks after therapy initiation
MRI-based brain perfusionPre-therapy and 4 weeks after therapy initiation
MRI-based brain morphologyPre-therapy and 4 weeks after therapy initiation
MRI-based diffusion imagingPre-therapy and 4 weeks after therapy initiation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026