Neuroimaging for Depression

Depression Clinical Trial

Official title:

Objective Detection, Evaluation and Countermeasures for In-flight Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00864630
• Other study ID #: NSBRI-NBFP01301
• Status: Terminated
• Phase: N/A
• First received: March 17, 2009
• Last updated: May 23, 2011
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Computer-based problem solving therapy
Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging		Pre-therapy and 4 weeks after therapy initiation	No
Secondary	Functional near infrared neuroimaging		Pre-therapy and 2 and 4 weeks after therapy initiation	No
Secondary	MRI-based brain perfusion		Pre-therapy and 4 weeks after therapy initiation	No
Secondary	MRI-based brain morphology		Pre-therapy and 4 weeks after therapy initiation	No
Secondary	MRI-based diffusion imaging		Pre-therapy and 4 weeks after therapy initiation	No