SchizophreniaNCT03068806
Brain Imaging, Attention, and Auditory Processing in Schizophrenia
An observational study of Schizophrenia, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial summary
This is a research study designed to examine how the psychiatric illness called schizophrenia affects brain function and thinking abilities such as attention and memory during simple computer-based tasks, and how measures of brain function are related to performance. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to 11 May 2018
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been diagnosed with schizophrenia and meet our research criteria of symptoms indicative of a diagnosis of schizophrenia within their lifetime are eligible for this study. Healthy controls who have never met criteria for a psychiatric disorder and meet our research criteria will also be included in this study.
Who may be able to join
- The subject population will include 18 to 75 year old participants of any gender, race, and ethnicity. All subjects will be able to speak and understand English.
- Schizophrenia subjects:
- 1. Patients must be diagnosed with DSM-IV schizophrenia, schizophreniform, or schizoaffective disorder based on a SCID-P interview.
- Comparison subjects:
- 1. Control participants must not have past or present Axis I diagnosis as determined by the SCID-NP.
Who cannot join
- All subjects:
- A hearing deficit greater than 40dB in both ears detected during the hearing test
- Substance dependence, as per clinical judgment, in the past 1 year (except caffeine and nicotine)
- A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological
- History of head injury with loss of consciousness greater than 15 minutes
- Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
Show all 9Show fewer
- Non-English speaking.
- Comparison subjects:
- 1. Any first-degree relative with schizophrenia or bipolar disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: Predictive Coding Abnormalities in Psychosis: EEG and fMRI
This is a research study designed to examine how the psychiatric illness called schizophrenia affects brain function and thinking abilities such as attention and memory during simple computer-based tasks, and how measures of brain function are related to performance. The investigators do this by looking at brain activity using electroencephalography (EEG) and magnetic resonance imaging (MRI). The investigators compare participants' results to the activity in their brain as well as clinical measures and questionnaires also completed during this study.
Read the detailed description
- EEG recording: In this procedure, the researcher will assess the participant's brain function while performing simple computer-based tasks. The computer tasks involve presentation of pictures or sounds to which the participant responds by pressing a button. The investigators will also record some of the participant's own speech sounds and play them back to them. The participant will be given clear instructions and a chance to practice before each task. While you are performing these tasks, the investigator will record the weak electrical signals produced by your brain, or "brain waves", using a technique called electroencephalography (EEG). In order to record the participant's EEG, sensors (small plastic discs) will be attached to specific locations on their scalp. The participant's scalp will be gently scrubbed before the sensors are attached. The sensors are held in place on the scalp using a nylon cap that fits snugly on the head. Sensors will also be attached above and below the participant's eyes and will record their eye movements. It will take approximately one hour to attach the sensors. The entire EEG will take approximately 2-3 hours. Before taking part in the EEG session, please make sure to wash hair and scalp. Do not use conditioner or a 2-in-1 shampoo/conditioner. The participant's hair should be dry before arrival. The investigators ask this in order to make the set-up process go more smoothly.
- During some tasks, participants will feel a vibratory sensation that is produced with an electrical current and it is possible that it may feel like a slight shock. The current is controlled and cannot reach levels that are painful or dangerous. Every participant experiences this sensation differently, so it is important that participants tell the researchers if the sensation becomes uncomfortable to you so the current can be adjusted or the task can be stopped.
- Participants may be asked to complete additional EEGs for this study, depending on your interest in participating and your availability. All EEG sessions will last approximately 2 hrs.
- MRI: In the fMRI procedure, we will use a magnet to measure blood flow to participants' brains while they do different tasks. Participants will be asked to lie down on a platform that can be slid into the middle of the magnet. A plastic MRI imaging coil will be placed around participants' heads. You will not come into contact with the coil during the experiment. Foam pads will be placed around the participant's head to limit head movement during the experiment. The investigators will then slide you into the magnet. At different points during the experiment, participants will be asked to do the same tasks they did in the training session prior to the scan. During the scan, participants will be asked to either lie still and rest, or do some tasks like tapping their fingers, remembering letters or digits, or viewing images that are designed to activate different parts of the brain. The entire MRI will take approximately two hours.
- While performing the MRI, participants may be asked to wear a cap that contains multiple EEG sensors applied to your scalp. A removable gel will be used. The EEG measures electrical activity produced by the brain while participants undergo the MRI. Set up for the EEG will take approximately 30 to 60 minutes.
- Participants may be asked to repeat an MRI session if the data the study team collects is not usable due to data quality issues, or if the participant is unable to stay awake in the magnet during your scan.
- Brief interview session: There will be a series of questions about participants' education, smoking status, and economic background. Participants will also be given a list of words to read to the researcher. If the participant is a patient diagnosed with one of the above-mentioned psychiatric disorders, they will be asked to participate in an additional interview, lasting about one hour, focusing on how they have been feeling recently.
- Behavioral testing: In this part, the participant will use a touch screen computer, mouse and/or paper and pencil to perform certain visual and auditory tests of your mental abilities. Specifically, these tests will assess participants' memory, attention, language, and motor skills. This testing will last approximately one hour. Depending on the participant's preference, this testing can be done on the same day as an EEG or on a different day. The order of the two sessions does not matter, so long as they occur within one week of each other.
Additional Information:
- If information about a participant's mental health is needed from their current or former doctor(s), they will be asked to sign a separate permission form before the researcher can contact their doctor(s).
- Conditions
- Schizophrenia
- Being tested
- Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)Diagnostic test
The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia and healthy controls.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Schizophrenia | Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime. Receives: Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI) | |
| Healthy Controls | Individuals who have not met criteria for a psychiatric disorder within their lifetime according to our research criteria for symptoms indicative of a psychiatric disorder. Receives: Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG
Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.
Measured: Day 1
MRI
Magnetic Resonance Imaging, measures activity in, and takes detailed pictures of the brain while participants conduct specific tasks that measure memory and attention.
Measured: Day 1
Memory and Attention tasks
Tasks involve saying words, pressing buttons at specific times, listening, and viewing pictures.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Dec 2014
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Judith Ford, San Francisco Veterans Affairs Medical Center
- Investigators
- Judith Ford, PhD, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068806
- Sponsor's protocol ID
- MH058262
- Status last verified
- Nov 2018
- First submitted
- 27 Feb 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Becsey L, Malamed S, Radnay P, Foldes FF. Reduction of the psychotomimetic and circulatory side-effects of ketamine by droperidol. Anesthesiology. 1972 Nov;37(5):536-42. doi: 10.1097/00000542-197211000-00016. No abstract available.
PubMed 4562467Bendikov I, Nadri C, Amar S, Panizzutti R, De Miranda J, Wolosker H, Agam G. A CSF and postmortem brain study of D-serine metabolic parameters in schizophrenia. Schizophr Res. 2007 Feb;90(1-3):41-51. doi: 10.1016/j.schres.2006.10.010. Epub 2006 Dec 6.
PubMed 17156977Broerse A, Crawford TJ, den Boer JA. Parsing cognition in schizophrenia using saccadic eye movements: a selective overview. Neuropsychologia. 2001;39(7):742-56. doi: 10.1016/s0028-3932(00)00155-x.
PubMed 11311304Clementz BA, McDowell JE, Zisook S. Saccadic system functioning among schizophrenia patients and their first-degree biological relatives. J Abnorm Psychol. 1994 May;103(2):277-87.
PubMed 8040497Crawford TJ, Sharma T, Puri BK, Murray RM, Berridge DM, Lewis SW. Saccadic eye movements in families multiply affected with schizophrenia: the Maudsley Family Study. Am J Psychiatry. 1998 Dec;155(12):1703-10. doi: 10.1176/ajp.155.12.1703.
PubMed 9842779Dedovic K, Renwick R, Mahani NK, Engert V, Lupien SJ, Pruessner JC. The Montreal Imaging Stress Task: using functional imaging to investigate the effects of perceiving and processing psychosocial stress in the human brain. J Psychiatry Neurosci. 2005 Sep;30(5):319-25.
PubMed 16151536Ford JM, Mathalon DH. Corollary discharge dysfunction in schizophrenia: can it explain auditory hallucinations? Int J Psychophysiol. 2005 Nov-Dec;58(2-3):179-89. doi: 10.1016/j.ijpsycho.2005.01.014. Epub 2005 Aug 31.
PubMed 16137779Ford JM, Mathalon DH, Marsh L, Faustman WO, Harris D, Hoff AL, Beal M, Pfefferbaum A. P300 amplitude is related to clinical state in severely and moderately ill patients with schizophrenia. Biol Psychiatry. 1999 Jul 1;46(1):94-101. doi: 10.1016/s0006-3223(98)00290-x.
PubMed 10394478Fukushima J, Fukushima K, Morita N, Yamashita I. Further analysis of the control of voluntary saccadic eye movements in schizophrenic patients. Biol Psychiatry. 1990 Dec 1;28(11):943-58. doi: 10.1016/0006-3223(90)90060-f.
PubMed 2275952Gordon E, Cooper N, Rennie C, Hermens D, Williams LM. Integrative neuroscience: the role of a standardized database. Clin EEG Neurosci. 2005 Apr;36(2):64-75. doi: 10.1177/155005940503600205.
PubMed 15999901Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
PubMed 8610818Hashimoto K, Engberg G, Shimizu E, Nordin C, Lindstrom LH, Iyo M. Reduced D-serine to total serine ratio in the cerebrospinal fluid of drug naive schizophrenic patients. Prog Neuropsychopharmacol Biol Psychiatry. 2005 Jun;29(5):767-9. doi: 10.1016/j.pnpbp.2005.04.023.
PubMed 15939521Hashimoto K, Fukushima T, Shimizu E, Komatsu N, Watanabe H, Shinoda N, Nakazato M, Kumakiri C, Okada S, Hasegawa H, Imai K, Iyo M. Decreased serum levels of D-serine in patients with schizophrenia: evidence in support of the N-methyl-D-aspartate receptor hypofunction hypothesis of schizophrenia. Arch Gen Psychiatry. 2003 Jun;60(6):572-6. doi: 10.1001/archpsyc.60.6.572.
PubMed 12796220Jaeger J, Berns SM, Czobor P. The multidimensional scale of independent functioning: a new instrument for measuring functional disability in psychiatric populations. Schizophr Bull. 2003;29(1):153-68. doi: 10.1093/oxfordjournals.schbul.a006987.
PubMed 12908671Katsanis J, Kortenkamp S, Iacono WG, Grove WM. Antisaccade performance in patients with schizophrenia and affective disorder. J Abnorm Psychol. 1997 Aug;106(3):468-72. doi: 10.1037//0021-843x.106.3.468.
PubMed 9241948
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Coding Abnormalities in Psychosis: EEG and fMRI
- ClinicalTrials.gov ID
- NCT03068806
- Acronym / sponsor ID
- MH058262
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 3 Mar 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.
This is a research study designed to examine how the psychiatric illness called schizophrenia affects brain function and thinking abilities such as attention and memory during simple computer-based tasks, and how measures of brain function are related to performance. The investigators do this by looking at brain activity using electroencephalography (EEG) and magnetic resonance imaging (MRI). The investigators compare participants' results to the activity in their brain as well as clinical measures and questionnaires also completed during this study.
Detailed description
- EEG recording: In this procedure, the researcher will assess the participant's brain function while performing simple computer-based tasks. The computer tasks involve presentation of pictures or sounds to which the participant responds by pressing a button. The investigators will also record some of the participant's own speech sounds and play them back to them. The participant will be given clear instructions and a chance to practice before each task. While you are performing these tasks, the investigator will record the weak electrical signals produced by your brain, or "brain waves", using a technique called electroencephalography (EEG). In order to record the participant's EEG, sensors (small plastic discs) will be attached to specific locations on their scalp. The participant's scalp will be gently scrubbed before the sensors are attached. The sensors are held in place on the scalp using a nylon cap that fits snugly on the head. Sensors will also be attached above and below the participant's eyes and will record their eye movements. It will take approximately one hour to attach the sensors. The entire EEG will take approximately 2-3 hours. Before taking part in the EEG session, please make sure to wash hair and scalp. Do not use conditioner or a 2-in-1 shampoo/conditioner. The participant's hair should be dry before arrival. The investigators ask this in order to make the set-up process go more smoothly.
- During some tasks, participants will feel a vibratory sensation that is produced with an electrical current and it is possible that it may feel like a slight shock. The current is controlled and cannot reach levels that are painful or dangerous. Every participant experiences this sensation differently, so it is important that participants tell the researchers if the sensation becomes uncomfortable to you so the current can be adjusted or the task can be stopped.
- Participants may be asked to complete additional EEGs for this study, depending on your interest in participating and your availability. All EEG sessions will last approximately 2 hrs.
- MRI: In the fMRI procedure, we will use a magnet to measure blood flow to participants' brains while they do different tasks. Participants will be asked to lie down on a platform that can be slid into the middle of the magnet. A plastic MRI imaging coil will be placed around participants' heads. You will not come into contact with the coil during the experiment. Foam pads will be placed around the participant's head to limit head movement during the experiment. The investigators will then slide you into the magnet. At different points during the experiment, participants will be asked to do the same tasks they did in the training session prior to the scan. During the scan, participants will be asked to either lie still and rest, or do some tasks like tapping their fingers, remembering letters or digits, or viewing images that are designed to activate different parts of the brain. The entire MRI will take approximately two hours.
- While performing the MRI, participants may be asked to wear a cap that contains multiple EEG sensors applied to your scalp. A removable gel will be used. The EEG measures electrical activity produced by the brain while participants undergo the MRI. Set up for the EEG will take approximately 30 to 60 minutes.
- Participants may be asked to repeat an MRI session if the data the study team collects is not usable due to data quality issues, or if the participant is unable to stay awake in the magnet during your scan.
- Brief interview session: There will be a series of questions about participants' education, smoking status, and economic background. Participants will also be given a list of words to read to the researcher. If the participant is a patient diagnosed with one of the above-mentioned psychiatric disorders, they will be asked to participate in an additional interview, lasting about one hour, focusing on how they have been feeling recently.
- Behavioral testing: In this part, the participant will use a touch screen computer, mouse and/or paper and pencil to perform certain visual and auditory tests of your mental abilities. Specifically, these tests will assess participants' memory, attention, language, and motor skills. This testing will last approximately one hour. Depending on the participant's preference, this testing can be done on the same day as an EEG or on a different day. The order of the two sessions does not matter, so long as they occur within one week of each other.
Additional Information:
- If information about a participant's mental health is needed from their current or former doctor(s), they will be asked to sign a separate permission form before the researcher can contact their doctor(s).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Schizophrenia | – | Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime. |
| Healthy Controls | – | Diagnostic Test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)Individuals who have not met criteria for a psychiatric disorder within their lifetime according to our research criteria for symptoms indicative of a psychiatric disorder. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with schizophrenia and meet our research criteria of symptoms indicative of a diagnosis of schizophrenia within their lifetime are eligible for this study. Healthy controls who have never met criteria for a psychiatric disorder and meet our research criteria will also be included in this study.
Key inclusion criteria (5 listed)
- The subject population will include 18 to 75 year old participants of any gender, race, and ethnicity. All subjects will be able to speak and understand English.
- 1. Patients must be diagnosed with DSM-IV schizophrenia, schizophreniform, or schizoaffective disorder based on a SCID-P interview.
- 1. Control participants must not have past or present Axis I diagnosis as determined by the SCID-NP.
Key exclusion criteria (9 listed)
- All subjects:
- 1. Any first-degree relative with schizophrenia or bipolar disorder.
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 |
|---|---|---|
| Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia and healthy controls. | Diagnostic test | Healthy Controls, Patients with Schizophrenia |
Primary outcome
EEG
Time frame: Day 1
Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.
MRI
Time frame: Day 1
Magnetic Resonance Imaging, measures activity in, and takes detailed pictures of the brain while participants conduct specific tasks that measure memory and attention.
Memory and Attention tasks
Time frame: Day 1
Tasks involve saying words, pressing buttons at specific times, listening, and viewing pictures.
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 30 Nov 2018.
- Background: PubMed 4562467Becsey L, Malamed S, Radnay P, Foldes FF. Reduction of the psychotomimetic and circulatory side-effects of ketamine by droperidol. Anesthesiology. 1972 Nov;37(5):536-42. doi: 10.1097/00000542-197211000-00016. No abstract available.
- Background: PubMed 17156977Bendikov I, Nadri C, Amar S, Panizzutti R, De Miranda J, Wolosker H, Agam G. A CSF and postmortem brain study of D-serine metabolic parameters in schizophrenia. Schizophr Res. 2007 Feb;90(1-3):41-51. doi: 10.1016/j.schres.2006.10.010. Epub 2006 Dec 6.
- Background: PubMed 11311304Broerse A, Crawford TJ, den Boer JA. Parsing cognition in schizophrenia using saccadic eye movements: a selective overview. Neuropsychologia. 2001;39(7):742-56. doi: 10.1016/s0028-3932(00)00155-x.
- Background: PubMed 8040497Clementz BA, McDowell JE, Zisook S. Saccadic system functioning among schizophrenia patients and their first-degree biological relatives. J Abnorm Psychol. 1994 May;103(2):277-87.
- Background: PubMed 9842779Crawford TJ, Sharma T, Puri BK, Murray RM, Berridge DM, Lewis SW. Saccadic eye movements in families multiply affected with schizophrenia: the Maudsley Family Study. Am J Psychiatry. 1998 Dec;155(12):1703-10. doi: 10.1176/ajp.155.12.1703.
- Background: PubMed 16151536Dedovic K, Renwick R, Mahani NK, Engert V, Lupien SJ, Pruessner JC. The Montreal Imaging Stress Task: using functional imaging to investigate the effects of perceiving and processing psychosocial stress in the human brain. J Psychiatry Neurosci. 2005 Sep;30(5):319-25.
- Background: PubMed 16137779Ford JM, Mathalon DH. Corollary discharge dysfunction in schizophrenia: can it explain auditory hallucinations? Int J Psychophysiol. 2005 Nov-Dec;58(2-3):179-89. doi: 10.1016/j.ijpsycho.2005.01.014. Epub 2005 Aug 31.
- Background: PubMed 10394478Ford JM, Mathalon DH, Marsh L, Faustman WO, Harris D, Hoff AL, Beal M, Pfefferbaum A. P300 amplitude is related to clinical state in severely and moderately ill patients with schizophrenia. Biol Psychiatry. 1999 Jul 1;46(1):94-101. doi: 10.1016/s0006-3223(98)00290-x.
- Background: PubMed 2275952Fukushima J, Fukushima K, Morita N, Yamashita I. Further analysis of the control of voluntary saccadic eye movements in schizophrenic patients. Biol Psychiatry. 1990 Dec 1;28(11):943-58. doi: 10.1016/0006-3223(90)90060-f.
- Background: PubMed 15999901Gordon E, Cooper N, Rennie C, Hermens D, Williams LM. Integrative neuroscience: the role of a standardized database. Clin EEG Neurosci. 2005 Apr;36(2):64-75. doi: 10.1177/155005940503600205.
- Background: PubMed 8610818Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.
- Background: PubMed 15939521Hashimoto K, Engberg G, Shimizu E, Nordin C, Lindstrom LH, Iyo M. Reduced D-serine to total serine ratio in the cerebrospinal fluid of drug naive schizophrenic patients. Prog Neuropsychopharmacol Biol Psychiatry. 2005 Jun;29(5):767-9. doi: 10.1016/j.pnpbp.2005.04.023.
- Brain Imaging and EEG Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Judith Ford, PhD principal investigator
San Francisco VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by San Francisco Veterans Affairs Medical Center 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 5 inclusion and 9 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 30 Nov 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?
EEG (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068806, which also lists 41 linked publications.
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 30 Nov 2018.