Trial Outcomes & Findings for Brain and Stress Study (NCT NCT06044090)

Last Updated: 2024-12-18

Results Overview

The aim of Probabilistic Reward Task (PRT) is to win as much money as possible by correctly identifying the presence of a short versus long mouth on a cartoon face. The task aims to produce a response bias toward the mouth length that is more often positively reinforced. The response bias score is a ratio of the number of times the participant chooses the high reward versus the low reward stimulus. Scores range from -1 to +1, with a positive score indicating a stronger bias toward the high reward stimulus. The change in response bias is calculated by subtracting response bias during the PRT in the placebo condition from the minocycline condition. This difference measures an individual's change in reward behavior after a 5-day dosage of an anti-neuroinflammatory agent.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo

Results posted on

2024-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Followed by Minocycline In this arm, participants will take a 5-day course of placebo-control pills and then a 5-day course of 200 mg of minocycline. Sessions will be separated by a minimum washout period of 14 days. Minocycline: Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day. Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.	Minocycline Followed by Placebo In this arm, participants will take a 5-day course of 200 mg of minocycline and then a 5-day course of placebo-control pills. Sessions will be separated by a minimum washout period of 14 days. Minocycline: Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day. Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
First Intervention (5 Days) STARTED	4	6
First Intervention (5 Days) COMPLETED	4	6
First Intervention (5 Days) NOT COMPLETED	0	0
Washout (14 Days) STARTED	4	6
Washout (14 Days) COMPLETED	4	6
Washout (14 Days) NOT COMPLETED	0	0
Second Intervention (5 Days) STARTED	4	4
Second Intervention (5 Days) COMPLETED	4	4
Second Intervention (5 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain and Stress Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=10 Participants Individuals who completed at least one treatment period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo

Outcome measures

Outcome measures
Measure	Minocycline n=10 Participants In this arm, participants will take a 5-day course of 200 mg of minocycline. Minocycline: Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.	Placebo n=8 Participants In this arm, participants will take a 5-day course of placebo-control pills. Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
Change in Response Bias During the Probabilistic Reward Task	0.195 Ratio (Response Bias Score) Standard Deviation 0.206	0.203 Ratio (Response Bias Score) Standard Deviation 0.199

SECONDARY outcome

Timeframe: within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo

The Snaith-Hamilton Pleasure Scale (SHAPS) is a tool to assess symptoms of reduced motivation. The SHAPS uses 14 questions, each rated on a Likert scale of 1-4. The total score on the scale ranges from 14-56, with lower scores reflecting lower motivation. Scores will be compared across conditions to determine whether motivation changes in the minocycline condition as compared to the placebo.

Outcome measures

Outcome measures
Measure	Minocycline n=10 Participants In this arm, participants will take a 5-day course of 200 mg of minocycline. Minocycline: Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.	Placebo n=8 Participants In this arm, participants will take a 5-day course of placebo-control pills. Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
Change in Snaith Hamilton Pleasure Scale Score	3.286 score on a scale Standard Deviation 1.590	2.933 score on a scale Standard Deviation 1.580

SECONDARY outcome

Timeframe: within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo

The Motivation and Pleasure Scale (MAP) will be used to capture self-reported aspects of reduced motivation. The scale uses 18 questions, each rated on a Likert scale of 0-4. The total score on the scale ranges from 0-72, with lower scores reflecting lower motivation. Scores will be compared across conditions to determine whether motivation changes in the minocycline condition as compared to the placebo.

Outcome measures

Outcome measures
Measure	Minocycline n=10 Participants In this arm, participants will take a 5-day course of 200 mg of minocycline. Minocycline: Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.	Placebo n=8 Participants In this arm, participants will take a 5-day course of placebo-control pills. Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
Change in Motivation and Pleasure Scale (MAPS) Score	37.786 score on a scale Standard Deviation 10.984	39.267 score on a scale Standard Deviation 12.870

Adverse Events

Minocycline

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Gabriella Alvarez, PhD

University of Pittsburgh

Phone: 412-624-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Minocycline n=10 participants at risk In this arm, participants will take a 5-day course of 200 mg of minocycline. Minocycline: Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.	Placebo n=8 participants at risk In this arm, participants will take a 5-day course of placebo-control pills. Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
Gastrointestinal disorders Nausea	30.0% 3/10 • Number of events 7 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Gastrointestinal disorders Vomiting	30.0% 3/10 • Number of events 7 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Gastrointestinal disorders Loss of Appetite	50.0% 5/10 • Number of events 6 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	12.5% 1/8 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Gastrointestinal disorders Stomach Ache	0.00% 0/10 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	12.5% 1/8 • Number of events 4 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Gastrointestinal disorders Stomach Pain	20.0% 2/10 • Number of events 5 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Gastrointestinal disorders Flatulence	20.0% 2/10 • Number of events 4 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	12.5% 1/8 • Number of events 2 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Gastrointestinal disorders Diarrhea	40.0% 4/10 • Number of events 6 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Nervous system disorders Lightheadedness	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 2 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Skin and subcutaneous tissue disorders Itching	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
General disorders Interrupted Sleep	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
General disorders Night Terrors	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Psychiatric disorders A sense of unrealness	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
Musculoskeletal and connective tissue disorders Lower Back Pain	10.0% 1/10 • Number of events 1 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	0.00% 0/8 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.
General disorders General Discomfort	0.00% 0/10 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.	12.5% 1/8 • Number of events 4 • Primary systematic adverse event collection occurred during the two 5-day treatment periods. Any non-systematic adverse event occuring during washout was included. The overall collection period was a combined total of 24 days.