Trial Outcomes & Findings for Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients (NCT NCT01043432)

Last Updated: 2015-05-12

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

133 participants

Primary outcome timeframe

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.

Results posted on

2015-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	22	51	12	48
Overall Study COMPLETED	22	51	12	48
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate/Severe TBI and History of Suicidal Behavior Group 1 n=22 Participants Moderate/severe TBI and history of suicidal behavior	Moderate/Severe TBI and no History of Suicidal behaviorGroup 2 n=51 Participants Moderate/Severe TBI and no history of suicidal behavior	No TBI and a History of Suicidal Behavior Group 3 n=12 Participants No TBI and a history of suicidal behavior	No TBI and no History of Suicidal Behavior Group 4 n=48 Participants No TBI and no history of suicidal behavior	Total n=133 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	51 Participants n=7 Participants	12 Participants n=5 Participants	48 Participants n=4 Participants	133 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	49.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	53 years STANDARD_DEVIATION 8.5 • n=7 Participants	51.7 years STANDARD_DEVIATION 12 • n=5 Participants	54.2 years STANDARD_DEVIATION 7.6 • n=4 Participants	52.7 years STANDARD_DEVIATION 8.9 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	51 Participants n=7 Participants	8 Participants n=5 Participants	40 Participants n=4 Participants	118 Participants n=21 Participants
Region of Enrollment United States	22 participants n=5 Participants	51 participants n=7 Participants	12 participants n=5 Participants	48 participants n=4 Participants	133 participants n=21 Participants
History of TBI (Present or Absent) - Lifetime OSU TBI-ID	22 participants n=5 Participants	51 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	73 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 n=22 Participants Moderate/severe TBI and history of suicidal behavior	Group 2 n=50 Participants Moderate/Severe TBI and no history of suicidal behavior	Group 3 n=12 Participants No TBI and a history of suicidal behavior	Group 4 n=48 Participants No TBI and no history of suicidal behavior
Iowa Gambling Test	-4.2 Total Raw on a scale from -100 to 100 Standard Deviation 27.7	1.7 Total Raw on a scale from -100 to 100 Standard Deviation 26.6	3.5 Total Raw on a scale from -100 to 100 Standard Deviation 24.5	5.3 Total Raw on a scale from -100 to 100 Standard Deviation 25.5

Adverse Events

All Groups

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa A. Brenner

Rocky Mountain MIRECC

Phone: 303-399-8020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place