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Emotional Response in Psychiatric and Control Participants

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ClinicalTrials.gov Identifier: NCT03056781
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Martin, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date December 14, 2018
Actual Study Start Date  ICMJE February 15, 2017
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Social Anhedonia Scale [ Time Frame: 1 day ]
    measures social anhedonia
  • Physical Anhedonia Scale [ Time Frame: 1 day ]
    measures physical anhedonia
  • EEG activity [ Time Frame: 1 day ]
    physiological parameter
  • Verbal behavioral rating [ Time Frame: 1 day ]
    how many words are spoken throughout the task
  • Non-verbal behavioral rating [ Time Frame: 1 day ]
    how many gestures are made throughout the task
  • International Personality Item Pool questionnaires [ Time Frame: 1 day ]
    measure of personality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Following Affective States test [ Time Frame: 1 day ]
    questionnaire re: how much participants follow or ignore their emotions
  • AMNART [ Time Frame: 1 day ]
    measure of verbal IQ
  • MMSE [ Time Frame: 1 day ]
    measure of mental status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotional Response in Psychiatric and Control Participants
Official Title  ICMJE Emotional Response in Psychiatric and Control Participants
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Schizophrenia
  • Emotions
Intervention  ICMJE
  • Behavioral: social interaction
    Participants will engage in a social interaction with another person
  • Behavioral: food consumption
    Participants will be offered food stuffs to eat/drink
Study Arms  ICMJE
  • Experimental: social interaction
    Participants will engage in a social interaction with another person
    Intervention: Behavioral: social interaction
  • Experimental: food consumption
    Participants will be offered food stuffs to eat/drink
    Intervention: Behavioral: food consumption
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2018)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
225
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056781
Other Study ID Numbers  ICMJE 2016-2945
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth A. Martin, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Irvine
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP