DepressionNCT00864630
Neuroimaging for Depression
A study testing Computer-based problem solving therapy in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Computer-based problem solving therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV criteria for minor or major depression
- Written informed consent
- Age 30-60 years (age of individuals currently in the astronaut corps)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Objective Detection, Evaluation and Countermeasures for In-flight Depression
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Computer-based problem solving therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based problem solving therapyBehavioural
Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.
| Study group | Role | What they receive |
|---|---|---|
| Wait list | No intervention | Not described |
| Computer-based problem solving therapy | Experimental | Not described Receives: Behavioral: Computer-based problem solving therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging
Measured: Pre-therapy and 4 weeks after therapy initiation
Secondary outcomes (4)
Functional near infrared neuroimaging
Measured: Pre-therapy and 2 and 4 weeks after therapy initiation
MRI-based brain perfusion
Measured: Pre-therapy and 4 weeks after therapy initiation
MRI-based brain morphology
Measured: Pre-therapy and 4 weeks after therapy initiation
MRI-based diffusion imaging
Measured: Pre-therapy and 4 weeks after therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startSep 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: The study upon which this project depended for subjects and the intervention was terminated prematurely due to lack of funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Emory University
- Investigators
- Gary E Strangman, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864630
- Sponsor's protocol ID
- NSBRI-NBFP01301
- Status last verified
- May 2011
- First submitted
- 17 Mar 2009
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Detection, Evaluation and Countermeasures for In-flight Depression
- ClinicalTrials.gov ID
- NCT00864630
- Acronym / sponsor ID
- NSBRI-NBFP01301
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study upon which this project depended for subjects and the intervention was terminated prematurely due to lack of funds.
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Emory University
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait list | No intervention | – |
| Computer-based problem solving therapy | Experimental | Behavioral: Computer-based problem solving therapy |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-IV criteria for minor or major depression
- Written informed consent
- Age 30-60 years (age of individuals currently in the astronaut corps)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based problem solving therapyComputer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA. | Behavioural | Computer-based problem solving therapy |
Primary outcome
Functional magnetic resonance imaging
Time frame: Pre-therapy and 4 weeks after therapy initiation
4 secondary outcomes
Functional near infrared neuroimaging
Time frame: Pre-therapy and 2 and 4 weeks after therapy initiation
MRI-based brain perfusion
Time frame: Pre-therapy and 4 weeks after therapy initiation
MRI-based brain morphology
Time frame: Pre-therapy and 4 weeks after therapy initiation
MRI-based diffusion imaging
Time frame: Pre-therapy and 4 weeks after therapy initiation
Results and safety
The study was stopped early (reason given: The study upon which this project depended for subjects and the intervention was terminated prematurely due to lack of funds.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary E Strangman, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based problem solving therapy in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study upon which this project depended for subjects and the intervention was terminated prematurely due to lack of funds.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional magnetic resonance imaging (time frame: Pre-therapy and 4 weeks after therapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2011.