Use of Multiple Brain Imaging Modalities (PET and MRS) to... | NCT01465165

Studies
Use of Multiple Brain Imaging Modalities (PET and MRS) to Identify Metabolic Abnormalities in Major Depression

NCT01465165

Sponsor

Paul Carlson

Status

Terminated

Last Update Posted

May 19, 2017Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Major Depressive Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study procedures were not feasible.

Expanded Access Info

Start Date

May 15, 2011Actual

Primary Completion Date

Jun 24, 2012Actual

Completion Date

Jun 24, 2012Actual

First Submitted Date

Nov 1, 2011

First Submission Date that Met QC Criteria

Nov 3, 2011

First Posted Date

Nov 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2017

Last Update Posted Date

May 19, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paul Carlson, Assistant Professor, University of UtahSponsor-Investigator

Lead Sponsor

Paul CarlsonOTHER

Collaborators

Name	Class
Western Institute for Biomedical Research	UNKNOWN
University of Utah	OTHER
Molecular Imaging Program, Huntsman Cancer Institute	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. The current study utilizes two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission tomography (PET) and multinuclear magnetic resonance spectroscopy (MRS), to better understand the nature of these metabolic abnormalities in major depressive disorder (MDD). The investigators hypothesize that individuals with depression will have increased metabolic activity as measured by PET in certain brain regions involved in mood regulation, but that this metabolic activity will be inefficient based on MRS findings. For this study, the investigators will study 10 medication-free, currently depressed participants with recurrent MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication, and up to 20 healthy control participants matched to depressed participants for age and gender. Depressed and healthy participants will each undergo one PET scan and one MRS scanning session.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Depressed, unmedicated		Participants with MDD who are not treated with any antidepressant medication
Depressed, on antidepressant		Participants with MDD, currently depressed but on a stable dose of an SSRI antidepressant
Healthy control		Healthy participant with no MDD or other psychiatric condition, matched by age and gender to MDD participants

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
high energy phosphate metabolites (Phosphocreatine (PCr)) as measured by magnetic resonance spectroscopy	relative concentration of Pcr	cross-sectional

Secondary Outcomes

Measure	Description	Time Frame
regional cerebral glucose metabolism, as measured by Positron Emission Tomography (PET)	binding potential of FDG	cross-sectional
N-Acetyl-Aspartate (NAA) metabolite intensity, as measured by proton Magnetic Resonance Spectroscopy (MRS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet DSM-IV criteria for Major Depressive Disorder (MDD), Recurrent
Montgomery-Asberg Depression Rating Scale (MADRS) score > 18

Exclusion Criteria:

Any coexisting psychiatric illness other than generalized anxiety disorder, panic disorder, or social/specific phobias
Any history of substance dependence
Substance abuse within the past 6 months
Significant risk of suicide, as defined by score >4 on item 10 of the MADRS or in the clinical judgment of the study physician
Any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of MRS or PET imaging
For the subset of unmedicated MDD patients, any psychotropic medications within 4 weeks prior to scanning. For the subgroup of medicated patients, they may be taking a stable dose (i.e., same dose for at least 4 weeks at the time of scanning) of standard antidepressant medications, but may not be taking any other psychotropic medication.
Inability to give informed consent
Contraindication to MRI (e.g., pacemaker, ferromagnetic implants in the body)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul J Carlson, M.D.	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah Dept of Psychiatry		Salt Lake City	Utah	84112	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified scanning images may be individually examined after the study is completed if new analysis methods become available to collaborators.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided