Neuroimaging for Depression

This study has been terminated.
(The study upon which this project depended for subjects and the intervention was terminated prematurely due to lack of funds.)
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Emory University
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00864630
First received: March 17, 2009
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Depression
Behavioral: Computer-based problem solving therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Objective Detection, Evaluation and Countermeasures for In-flight Depression

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Functional magnetic resonance imaging [ Time Frame: Pre-therapy and 4 weeks after therapy initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional near infrared neuroimaging [ Time Frame: Pre-therapy and 2 and 4 weeks after therapy initiation ] [ Designated as safety issue: No ]
  • MRI-based brain perfusion [ Time Frame: Pre-therapy and 4 weeks after therapy initiation ] [ Designated as safety issue: No ]
  • MRI-based brain morphology [ Time Frame: Pre-therapy and 4 weeks after therapy initiation ] [ Designated as safety issue: No ]
  • MRI-based diffusion imaging [ Time Frame: Pre-therapy and 4 weeks after therapy initiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait list
Experimental: Computer-based problem solving therapy Behavioral: Computer-based problem solving therapy
Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864630

Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Emory University
Investigators
Principal Investigator: Gary E Strangman, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Gary Strangman, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00864630     History of Changes
Other Study ID Numbers: NSBRI-NBFP01301
Study First Received: March 17, 2009
Last Updated: May 23, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 30, 2014