Trial Outcomes & Findings for Neurosteroids in PTSD - Biomarkers to Therapeutics (NCT NCT03491007)

NCT ID: NCT03491007

Last Updated: 2023-05-06

Results Overview

The Shifted-Attention Emotion Appraisal (SEAT) Paradigm will present compound stimuli that include both emotional faces (e.g. sad, happy, angry) and neutral scenes. In three different conditions, participants are asked to respond to three different questions: (1) 'Gender'; (2) 'Inside/Outside'; or (3) 'Like/Dislike'. This allows multiple components of cognition to be probed including (1) implicit emotional processing, (2) attentional modulation, and (3) cognitive modulation of emotion. Item-specific memory will be tested first using yes/no recognition judgments. The conjunctive memory test will require participants to make "match" (previously viewed faces and buildings presented in a combinations seen during encoding) or "mismatch" (items in combinations not previously seen together) judgments. Change in SEAT paradigm (Z score) from baseline to 6 weeks

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2023-05-06

Participant Flow

Participant milestones

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Overall Study STARTED	3	2
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurosteroids in PTSD - Biomarkers to Therapeutics

Baseline characteristics by cohort

Measure	Placebo n=3 Participants Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=2 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	34.33 Years STANDARD_DEVIATION 2.87 • n=93 Participants	34.00 Years STANDARD_DEVIATION 5 • n=4 Participants	34.2 Years STANDARD_DEVIATION 3.87 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Neuroimaging data not available. Software setup and code creation for fMRI analyses was intended to occur after all participants had been enrolled and all scans had been performed (and available to be analyzed). Study was terminated prior to full participation and the data needed was simply not collected.

The Shifted-Attention Emotion Appraisal (SEAT) Paradigm will present compound stimuli that include both emotional faces (e.g. sad, happy, angry) and neutral scenes. In three different conditions, participants are asked to respond to three different questions: (1) 'Gender'; (2) 'Inside/Outside'; or (3) 'Like/Dislike'. This allows multiple components of cognition to be probed including (1) implicit emotional processing, (2) attentional modulation, and (3) cognitive modulation of emotion. Item-specific memory will be tested first using yes/no recognition judgments. The conjunctive memory test will require participants to make "match" (previously viewed faces and buildings presented in a combinations seen during encoding) or "mismatch" (items in combinations not previously seen together) judgments. Change in SEAT paradigm (Z score) from baseline to 6 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make a diagnosis of PTSD and assess PTSD symptoms. It assesses the intensity and frequency of PTSD symptoms. Change in total CAPS-5 score from baseline to 6 weeks. Scores range from 0-80; higher score indicates greater severity.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	—	-5 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). Change in total BDI-II score from baseline to 6 weeks. Higher score indicates greater severity.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Beck-Depression Inventory-II (BDI-II)	—	-12 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The HAM-A is clinician-rated interview that measures presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56. Higher score indicates greater anxiety. Change in total HAM-A score from baseline to 6 weeks

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Hamilton Anxiety Rating Scale (HAM-A)	—	-3 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

Change in total SCL-90-R score (range: 90 to 450; higher score indicates greater severity) from baseline to 6 weeks. This scale assesses somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Symptom Checklist-90-Revised (SCL-90-R)	—	-8 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

PROMIS Pain Intensity is a three item scale measuring the severity of pain using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5).Change in total PROMIS Pain Intensity Scale score (range: 3 to 15) from baseline to 6 weeks. Higher score indicates greater severity.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity Scale	—	0 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The 8-item PROMIS Sleep Disturbance measures sleep disturbance with each item on the measure rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8-40. Change in total PROMIS-Sleep Disturbance score from baseline to 6 weeks. Higher score indicates greater severity.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale	—	1 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The PROMIS-Anger Scale is an 8-item scale that assesses anger. Scores range from 5 to 25, with higher scores indicating greater anger severity. Change in total PROMIS-Anger score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
PROMIS-Anger Scale	—	0 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The BIS-11 is a 30 item questionnaire to measure impulsiveness. Items are answered on a 4-point scale. Total scores range from 30-120 with a higher summed score indicating higher impulsivity. Change in total BIS-11 score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Barrat Impulsivity Scale (BIS-11)	—	-15 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The CD-RISC scale assesses resiliency in individuals. There are 25 items in the survey, each item is scored from 0-4, and the total ranges from 0-100. Higher scores indicate greater resilience. Change in total CD-RISC score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Connor-Davidson Resilience Scale (CD-RISC)	—	20 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The HAM-D is a standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Total scores range from 0-50. Higher score indicates greater severity. Change in total HAM-D score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Hamilton Depression Ratings Scale (HAM-D)	—	2 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

PROMIS-Depression Scale is a self-reported scale of depressive symptoms Each item is scored 1-5 (1 = Never; 5 = Always). Total ranges are 8 to 40. Higher score indicates greater severity. Change in total PROMIS Depression score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Scale	—	-2 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The PROMIS-Anxiety Scale is a self-report of anxiety symptoms. Each item is scored 1-5 (1 = Never; 5 = Always). Total score ranges from 8 to 40. Higher score indicates greater severity. Change in total PROMIS Anxiety score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Scale	—	-4 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The CGI scale will be used to rate improvement in the subject's condition. Total score range of 0-30. Higher scores indicates greater severity. Change in total CGI score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Clinician Global Impression Scale (CGI)	—	-3 score on a scale (change score)

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Study was terminated prior to analysis (PI obtained outside employment that was not compatible with this award). Only one participant completed the study (randomized to DHEA); only this one participant thus had data for the primary outcome measure (change from baseline to study completion for primary endpoint). Only one other participant had post-randomization data (randomized to placebo x 2 weeks then withdrew from study).

The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning. Total range of 0-110. Higher score indicates greater severity. Change in total BPI score from baseline to 6 weeks.

Outcome measures

Measure	Placebo Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=1 Participants Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
Brief Pain Inventory (BPI)	—	-5 score on a scale (change score)

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Change in serum levels of DHEA from baseline to 6 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Change in STI (Z score) from baseline to 6 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Change in serum DHEAS levels from baseline to 6 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Change in serum androsterone levels from baseline to 6 weeks

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

DHEA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=3 participants at risk Subjects will receive a one-time oral dose of PBO prior to initial brain imaging followed by sustained administration of PBO for 6 weeks.	DHEA n=2 participants at risk Subjects will receive a one-time oral dose of DHEA prior to initial brain imaging followed by sustained administration of DHEA for 6 weeks. DHEA: Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period \[all participants\], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
General disorders Drowsiness	33.3% 1/3 • Number of events 1 • Adverse Event data was collected at each visit throughout study participation and by phone two weeks post study completion, up to 10 weeks.	0.00% 0/2 • Adverse Event data was collected at each visit throughout study participation and by phone two weeks post study completion, up to 10 weeks.
General disorders Restlessness	33.3% 1/3 • Number of events 1 • Adverse Event data was collected at each visit throughout study participation and by phone two weeks post study completion, up to 10 weeks.	0.00% 0/2 • Adverse Event data was collected at each visit throughout study participation and by phone two weeks post study completion, up to 10 weeks.
General disorders Decreased Appetite	33.3% 1/3 • Number of events 1 • Adverse Event data was collected at each visit throughout study participation and by phone two weeks post study completion, up to 10 weeks.	0.00% 0/2 • Adverse Event data was collected at each visit throughout study participation and by phone two weeks post study completion, up to 10 weeks.

Additional Information

Susan O'Loughlin

Durham VA Healthcare Center

Phone: 919-286-0411

Email: susan.o'loughlin@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place