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Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01043432
First received: January 4, 2010
Last updated: April 21, 2015
Last verified: April 2015
Results First Received: February 11, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions: Traumatic Brain Injury
Suicidality

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 Moderate/severe TBI and history of suicidal behavior = 22
Group 2 Moderate/Severe TBI and no history of suicidal behavior = 51
Group 3 No TBI and a history of suicidal behavior = 12
Group 4 No TBI and no history of suicidal behavior = 48

Participant Flow:   Overall Study
    Group 1   Group 2   Group 3   Group 4
STARTED   22   51   12   48 
COMPLETED   22   51   12   48 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Moderate/Severe TBI and History of Suicidal Behavior Group 1 Moderate/severe TBI and history of suicidal behavior
Moderate/Severe TBI and no History of Suicidal behaviorGroup 2 Moderate/Severe TBI and no history of suicidal behavior
No TBI and a History of Suicidal Behavior Group 3 No TBI and a history of suicidal behavior
No TBI and no History of Suicidal Behavior Group 4 No TBI and no history of suicidal behavior
Total Total of all reporting groups

Baseline Measures
   Moderate/Severe TBI and History of Suicidal Behavior Group 1   Moderate/Severe TBI and no History of Suicidal behaviorGroup 2   No TBI and a History of Suicidal Behavior Group 3   No TBI and no History of Suicidal Behavior Group 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   51   12   48   133 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   22   51   12   48   133 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.5  (10.3)   53  (8.5)   51.7  (12)   54.2  (7.6)   52.7  (8.9) 
Gender 
[Units: Participants]
         
Female   3   0   4   8   15 
Male   19   51   8   40   118 
Region of Enrollment 
[Units: Participants]
         
United States   22   51   12   48   133 
History of TBI (Present or Absent) - Lifetime OSU TBI-ID [1] 
[Units: Participants]
 22   51   0   0   73 
[1] Lifetime History TBI (Present or Absent)


  Outcome Measures

1.  Primary:   Iowa Gambling Test   [ Time Frame: One time - for the vast majority of participants the research protocol was initiated directly after informed consent procedures were completed (within hours). Negative values are possible with this measure, see Outcome Description. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Majority of control group had lifetime history of psychiatric disorders Significant challenges with recruiting


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lisa A. Brenner
Organization: Rocky Mountain MIRECC
phone: 303-399-8020 ext 2571
e-mail: lisa.brenner@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01043432     History of Changes
Other Study ID Numbers: D7210-R
Study First Received: January 4, 2010
Results First Received: February 11, 2015
Last Updated: April 21, 2015
Health Authority: United States: Federal Government