Trial Outcomes & Findings for Translational Model of Anhedonia (NCT NCT03856177)
NCT ID: NCT03856177
Last Updated: 2024-03-29
Results Overview
The Reward Positivity is a fronto-centrally located positive voltage burst recorded in the EEG from about 200-500 ms following the receipt of a reinforcing outcome (e.g. money, points). Higher voltages (more positive numbers) indicate a larger reward response.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
There will only be one day session (on the date of the randomization) where the Reward Positivity amplitude is assessed
Results posted on
2024-03-29
Participant Flow
Participants were run in the Cognitive Rhythms and Computation Lab at UNM from 6/13/19 - 5/7/21
There are no significant events to describe between enrollment and assignment.
Participant milestones
| Measure |
Neutral
A neutral mood induction will include reading a dull text while listening to non-evocative music for 5-15 minutes.
Emotion Induction: Described in arm
|
Evocative
A mood induction procedure will be utilized. The procedure consists of a combination of re-experiencing an autobiographical sad personal event while listening to their choice of one of four sad music selections commonly used in mood induction. Visual analogue scale ratings will assess momentary sadness prior to, following, and at subsequent time points around the mood induction procedure.
Emotion Induction: Described in arm
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Translational Model of Anhedonia
Baseline characteristics by cohort
| Measure |
Neutral
n=50 Participants
A neutral mood induction will include reading a dull text while listening to non-evocative music for 5-15 minutes.
Emotion Induction: Described in arm
|
Evocative
n=50 Participants
A mood induction procedure will be utilized. The procedure consists of a combination of re-experiencing an autobiographical sad personal event while listening to their choice of one of four sad music selections commonly used in mood induction. Visual analogue scale ratings will assess momentary sadness prior to, following, and at subsequent time points around the mood induction procedure.
Emotion Induction: Described in arm
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: There will only be one day session (on the date of the randomization) where the Reward Positivity amplitude is assessedThe Reward Positivity is a fronto-centrally located positive voltage burst recorded in the EEG from about 200-500 ms following the receipt of a reinforcing outcome (e.g. money, points). Higher voltages (more positive numbers) indicate a larger reward response.
Outcome measures
| Measure |
Neutral
n=50 Participants
A neutral mood induction will include reading a dull text while listening to non-evocative music for 5-15 minutes.
Emotion Induction: Described in arm
|
Evocative
n=50 Participants
A mood induction procedure will be utilized. The procedure consists of a combination of re-experiencing an autobiographical sad personal event while listening to their choice of one of four sad music selections commonly used in mood induction. Visual analogue scale ratings will assess momentary sadness prior to, following, and at subsequent time points around the mood induction procedure.
Emotion Induction: Described in arm
|
|---|---|---|
|
Reward Positivity Component of the Event-Related Electroencephalogram
|
7.29 Microvolts
Standard Deviation 3.78
|
9.23 Microvolts
Standard Deviation 3.64
|
Adverse Events
Neutral
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evocative
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place