NCT03856177

Brief Summary

The proposed research addresses a major mental health issue (anhedonia) with a novel computationally-inspired translational technique in both humans and mice. This approach greatly increases the likelihood that a positive animal model result will be successfully translated to humans. This research plan thus offers a novel way to address the NIMH's mission of defining mechanisms of complex behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 24, 2023

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

February 21, 2019

Results QC Date

February 17, 2023

Last Update Submit

March 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reward Positivity Component of the Event-Related Electroencephalogram

    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.

    There will only be one day session (on the date of the randomization) where the Reward Positivity amplitude is assessed

Study Arms (2)

Neutral

EXPERIMENTAL

A neutral mood induction will include reading a dull text while listening to non-evocative music for 5-15 minutes.

Behavioral: Emotion Induction

Evocative

EXPERIMENTAL

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.

Behavioral: Emotion Induction

Interventions

Described in arm

EvocativeNeutral

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women aged 18-55
  • Free from psychoactive medication for at least 2 weeks

You may not qualify if:

  • Participants unwilling or unable to give informed consent
  • Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
  • History of psychosis
  • Not fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico - Logan hall

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Anhedonia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. James F. Cavanagh
Organization
University of New Mexico

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Randomization will be based on the last digit (odd vs. even) of the participant's research identifier.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into neutral or emotionally evocative conditions prior to assessing EEG brain signals of reward.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 27, 2019

Study Start

April 1, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

March 29, 2024

Results First Posted

April 24, 2023

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations