MRI Imaging of Chronobiologic Abnormalities in Depression | NCT00178880

Studies
MRI Imaging of Chronobiologic Abnormalities in Depression

NCT00178880

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Depression

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008Actual

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

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

Mar 30, 2017

Last Update Posted Date

Apr 4, 2017Actual

Description Module

Brief Summary

The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.

Detailed Description

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

7Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

WEIGHT: less than or at 20% over ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical limitations in fitting overweight individuals into the scanner, and the risk of excessive claustrophobic responses if tightly constricted.
HEALTH: healthy, ambulatory normal or depressed adults

Exclusion Criteria:

Presence of aneurysm clips, cardiac pacemakers, cochlear implants, metal in the eyes, and implanted insulin pumps.
Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities.
Pregnancy.
Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Patients on antidepressants may not be taking any other medication, except at the discretion of the investigator. Untreated depressed or healthy subjects must be free of all medications except as approved by the investigator.
Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers and depressed patients.

Sampling Method

Non-Probability Sample

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior