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Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

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ClinicalTrials.gov Identifier: NCT01043432
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions Traumatic Brain Injury
Suicidality
Enrollment 133

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description Moderate/severe TBI and history of suicidal behavior = 22 Moderate/Severe TBI and no history of suicidal behavior = 51 No TBI and a history of suicidal behavior = 12 No TBI and no history of suicidal behavior = 48
Period Title: Overall Study
Started 22 51 12 48
Completed 22 51 12 48
Not Completed 0 0 0 0
Arm/Group Title 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
Hide Arm/Group Description Moderate/severe TBI and history of suicidal behavior Moderate/Severe TBI and no history of suicidal behavior No TBI and a history of suicidal behavior No TBI and no history of suicidal behavior Total of all reporting groups
Overall Number of Baseline Participants 22 51 12 48 133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 51 participants 12 participants 48 participants 133 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
51
 100.0%
12
 100.0%
48
 100.0%
133
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 51 participants 12 participants 48 participants 133 participants
49.5  (10.3) 53  (8.5) 51.7  (12) 54.2  (7.6) 52.7  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 51 participants 12 participants 48 participants 133 participants
Female
3
  13.6%
0
   0.0%
4
  33.3%
8
  16.7%
15
  11.3%
Male
19
  86.4%
51
 100.0%
8
  66.7%
40
  83.3%
118
  88.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 51 participants 12 participants 48 participants 133 participants
22 51 12 48 133
History of TBI (Present or Absent) - Lifetime OSU TBI-ID   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 51 participants 12 participants 48 participants 133 participants
22 51 0 0 73
[1]
Measure Description: Lifetime History TBI (Present or Absent)
1.Primary Outcome
Title Iowa Gambling Test
Hide Description Iowa Gambling Test - Total Raw Score The Iowa Gambling task requires examinees to sit in front of a computer screen displaying four decks of cards (Decks A, B, C, and D) and select a card from any of the four decks. Decks A and B are the disadvantageous decks because they produce high immediate gains however over time examinees will experience a higher loss. Decks C and D are the advantageous decks because they produce lower gains but over time examinees will experience smaller losses. Examinees will make 100 choices (trials). To measure performance, the 100 trials are divided, in order, into 5 'blocks’ of 20. A net score is calculated for each block as the number of cards selected from the advantageous decks minus the disadvantageous decks and the total raw score is the sum of the scores for blocks 1-5. The overall total score can range from -100 (worst outcome) to 100 (best outcome)and the score for each block can range from -20 to 20
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
Moderate/severe TBI and history of suicidal behavior
Moderate/Severe TBI and no history of suicidal behavior
No TBI and a history of suicidal behavior
No TBI and no history of suicidal behavior
Overall Number of Participants Analyzed 22 50 12 48
Mean (Standard Deviation)
Unit of Measure: Total Raw on a scale from -100 to 100
-4.2  (27.7) 1.7  (26.6) 3.5  (24.5) 5.3  (25.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Groups
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Groups
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Groups
Affected / at Risk (%)
Total   0/133 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Groups
Affected / at Risk (%)
Total   0/133 (0.00%) 
Majority of control group had lifetime history of psychiatric disorders Significant challenges with recruiting
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01043432     History of Changes
Other Study ID Numbers: D7210-R
First Submitted: January 4, 2010
First Posted: January 6, 2010
Results First Submitted: February 11, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015