NCT03056781

Brief Summary

The purpose of this research is to understand how the emotions of people with different mental health concerns (e.g., people with schizophrenia, people with major depressive disorder) differ from individuals without mental health concerns. A large body of literature suggests that people with mental illnesses have emotional abnormalities compared to healthy individuals, but a number of these abnormalities are not well understood. For example, often people with schizophrenia report on questionnaires that they experience fewer pleasant emotions when talking with other people, but some evidence suggests these individuals report a similar amount of pleasant emotion when they are actually engaged in a pleasant activity. Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more real-world setting. In the tasks in the current proposal, participants will engage in a series of tasks designed to assess their emotional functioning. These tasks involve viewing emotional stimuli on the computer, engaging in social interactions, and consuming small amounts of food. In all tasks, participants will make ratings of their experiences of pleasure (and displeasure). We will then compare the experiences of patient groups to those of healthy individuals to test how emotional ratings might differ across these tasks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable schizophrenia

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

January 3, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

January 3, 2017

Last Update Submit

December 12, 2018

Conditions

Outcome Measures

Primary Outcomes (6)

  • Social Anhedonia Scale

    measures social anhedonia

    1 day

  • Physical Anhedonia Scale

    measures physical anhedonia

    1 day

  • EEG activity

    physiological parameter

    1 day

  • Verbal behavioral rating

    how many words are spoken throughout the task

    1 day

  • Non-verbal behavioral rating

    how many gestures are made throughout the task

    1 day

  • International Personality Item Pool questionnaires

    measure of personality

    1 day

Secondary Outcomes (3)

  • Following Affective States test

    1 day

  • AMNART

    1 day

  • MMSE

    1 day

Study Arms (2)

social interaction

EXPERIMENTAL

Participants will engage in a social interaction with another person

Behavioral: social interaction

food consumption

EXPERIMENTAL

Participants will be offered food stuffs to eat/drink

Behavioral: food consumption

Interventions

Participants will engage in a social interaction with another person

social interaction

Participants will be offered food stuffs to eat/drink

food consumption

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For control participants, you are eligible to participate in this study if you are between 18 and 65 years of age, you are fluent in English, and you have not been clinically diagnosed with a psychiatric disorder.
  • For psychiatric patients, you are eligible to participate in this study if you are between 18 and 65 years of age, you are fluent in English, and you have been clinically diagnosed with schizophrenia, schizoaffective disorder, or depression with no recent hospitalization or changes in your psychiatric medications.

You may not qualify if:

  • For control participants, you are not eligible to participate in the study if you have a history of stroke or a current history of substance or alcohol dependence. You are also not eligible to participate in this study if you have had a diagnosis of substance abuse in the past three months. You are not eligible to participate if you have a current or past history of a major medical illness, significant tremors, a history of a head injury or prolonged unconsciousness.
  • For psychiatric patients, you are not eligible to participate in the study if you have had major changes to your psychotropic medications within the last two months, have a history of stroke or a current history of substance or alcohol dependence. You are also not eligible to participate in this study if you have had a diagnosis of substance abuse in the past three months, a current or past history of a major medical illness, significant tremors, or a history of a head injury or prolonged unconsciousness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social Ecology 1

Irvine, California, 92697-0001, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 3, 2017

First Posted

February 17, 2017

Study Start

February 15, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations