NCT01337908

Brief Summary

This is a study of factors, such as pain, family support, psychological history and alcohol/substance use, that may influence whether a person experiences depression after their spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
377

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

2.6 years

First QC Date

April 15, 2011

Last Update Submit

March 19, 2012

Conditions

Spinal Cord InjuryDepression

Keywords

depressionquality of lifedisability

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men and women with a traumatic spinal cord injury who are 18 years of age and older

You may qualify if:

  • Have a spinal cord injury
  • Were age 16 years or older when injured
  • Sudden onset of symptoms

You may not qualify if:

  • Under 19 years old
  • Less than 1 year post-injury
  • had a non-traumatic injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Rehabilitation Institute of Michigan

Detroit, Michigan, 48201, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples collected with Oragene kit.

MeSH Terms

Conditions

Spinal Cord InjuriesDepression

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 19, 2011

Study Start

February 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(4)