- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056781
Emotional Response in Psychiatric and Control Participants
December 12, 2018 updated by: Elizabeth A. Martin, University of California, Irvine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92697-0001
- Social Ecology 1
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: social interaction
Participants will engage in a social interaction with another person
|
Participants will engage in a social interaction with another person
|
|
Experimental: food consumption
Participants will be offered food stuffs to eat/drink
|
Participants will be offered food stuffs to eat/drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Anhedonia Scale
Time Frame: 1 day
|
measures social anhedonia
|
1 day
|
|
Physical Anhedonia Scale
Time Frame: 1 day
|
measures physical anhedonia
|
1 day
|
|
EEG activity
Time Frame: 1 day
|
physiological parameter
|
1 day
|
|
Verbal behavioral rating
Time Frame: 1 day
|
how many words are spoken throughout the task
|
1 day
|
|
Non-verbal behavioral rating
Time Frame: 1 day
|
how many gestures are made throughout the task
|
1 day
|
|
International Personality Item Pool questionnaires
Time Frame: 1 day
|
measure of personality
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Following Affective States test
Time Frame: 1 day
|
questionnaire re: how much participants follow or ignore their emotions
|
1 day
|
|
AMNART
Time Frame: 1 day
|
measure of verbal IQ
|
1 day
|
|
MMSE
Time Frame: 1 day
|
measure of mental status
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2017
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
January 3, 2017
First Submitted That Met QC Criteria
February 14, 2017
First Posted (Actual)
February 17, 2017
Study Record Updates
Last Update Posted (Actual)
December 14, 2018
Last Update Submitted That Met QC Criteria
December 12, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-2945
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
First Affiliated Hospital of Fujian Medical UniversityNot yet recruiting
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Newron Pharmaceuticals SPARecruitingTreatment-resistant SchizophreniaUnited States, India
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarCompletedTreatment Resistant SchizophreniaIndia
-
Central Institute of Mental Health, MannheimRecruitingSchizophrenia | Treatment Resistant SchizophreniaGermany
-
Shanghai Zhongze Therapeutics Co., Ltd.Yale UniversityNot yet recruiting
-
Ole Köhler-ForsbergAarhus University HospitalRecruiting
Clinical Trials on social interaction
-
Florida State UniversityNational Institute of Mental Health (NIMH)CompletedAutistic DisorderUnited States
-
University Hospital, MontpellierEuromov Digital Health in MotionRecruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)Completed
-
Samsung Medical CenterCompletedPediatricsKorea, Republic of
-
Bar-Ilan University, IsraelCompletedCognitive DeclineIsrael
-
Chapman UniversityAmerican Society for Surgery of the HandUnknownBrachial Plexus PalsyUnited States
-
Washington University School of MedicineUniversity of California, San Diego; University of Missouri, St. LouisTerminated
-
Helsinki University Central HospitalThe University of Texas Health Science Center at San Antonio; City of HelsinkiCompletedCognitive Function 1, Social | Psychotic DisorderFinland
-
The Hong Kong Polytechnic UniversityCompletedDepression | Quality of Life | Sleep | Dementia | AnxietyHong Kong
-
VA Connecticut Healthcare SystemCompleted