Trial Outcomes & Findings for Effects of Pregnenolone on Perceived Social Isolation (NCT NCT02826577)

Results Overview

Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event). Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-05-16

Participant Flow

No participants started the trial and received the intervention.

Participant milestones

Participant milestones
Measure	Pregnenolone 175mg \- Single dose of 175mg Pregnenolone 175mg: Single Dose 175mg	Pregnenolone 400mg \- Single dose of 400mg Pregnenolone 400mg: Single Dose 400mg	Placebo \- Single dose of placebo Placebo: Single Dose	Matched Healthy Controls \- No intervention
Overall Study STARTED	0	0	0	0
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Pregnenolone on Perceived Social Isolation

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 8 weeks

Population: No data was collected or analyzed due to Principal Investigator leaving the institution.

Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event). Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: No data was collected or analyzed due to Investigator leaving the institution.

Movements to first saccades. Change from baseline eye movement tracking results at 8 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Pregnenolone 175mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pregnenolone 400mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Matched Healthy Controls

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

Compliance Specialist

University of Chicago

Phone: 773-702-6505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place