SchizophreniaNCT03056781
Emotional Response in Psychiatric and Control Participants
A study testing social interaction and food consumption in people with Schizophrenia and Emotions, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Emotions
- What is being tested?
- social interaction and food consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Schizophrenia, Emotions
- Being tested
- social interaction, food consumption
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social interactionBehavioural
Participants will engage in a social interaction with another person
food consumptionBehavioural
Participants will be offered food stuffs to eat/drink
| Study group | Role | What they receive |
|---|---|---|
| social interaction | Experimental | Participants will engage in a social interaction with another person Receives: Behavioral: social interaction |
| food consumption | Experimental | Participants will be offered food stuffs to eat/drink Receives: Behavioral: food consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Anhedonia Scale
measures social anhedonia
Measured: 1 day
Physical Anhedonia Scale
measures physical anhedonia
Measured: 1 day
EEG activity
physiological parameter
Measured: 1 day
Verbal behavioral rating
how many words are spoken throughout the task
Measured: 1 day
Non-verbal behavioral rating
how many gestures are made throughout the task
Measured: 1 day
International Personality Item Pool questionnaires
measure of personality
Measured: 1 day
Secondary outcomes (3)
Following Affective States test
questionnaire re: how much participants follow or ignore their emotions
Measured: 1 day
AMNART
measure of verbal IQ
Measured: 1 day
MMSE
measure of mental status
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start15 Feb 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth A. Martin, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056781
- Sponsor's protocol ID
- 2016-2945
- Status last verified
- Dec 2018
- First submitted
- 3 Jan 2017
- Last updated
- 14 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Response in Psychiatric and Control Participants
- ClinicalTrials.gov ID
- NCT03056781
- Acronym / sponsor ID
- 2016-2945
- Conditions
- Schizophrenia, Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| social interaction | Experimental | Behavioral: social interactionParticipants will engage in a social interaction with another person |
| food consumption | Experimental | Behavioral: food consumptionParticipants will be offered food stuffs to eat/drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| social interactionParticipants will engage in a social interaction with another person | Behavioural | social interaction |
| food consumptionParticipants will be offered food stuffs to eat/drink | Behavioural | food consumption |
Primary outcome
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
3 secondary outcomes
Following Affective States test
Time frame: 1 day
AMNART
Time frame: 1 day
MMSE
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social interaction and food consumption in people with Schizophrenia and Emotions, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Anhedonia Scale (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.