PsychosisNCT03822910
Hippocampal Memory Circuits in Delusions
An observational study of Psychosis, run by NYU Langone Health at 3 sites in 2 countries.
Trial summary
This study will investigate dentate gyrus (DG) and hippocampal CA3 sub field function, using the pattern separation paradigm, as reflected by the difference in brain activation in response to same-as-previously- seen (OLD) vs. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Pattern Separation Paradigm, Sequential Associative Mismatch Paradigm and Encoding Plasticity Paradigm
- How many people
- 212 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Jul 2019to 12 Aug 2023
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Males and females with First Episode Psychosis
Who may be able to join
- Males and females 16 to 35 years of age, inclusive, at the time of informed consent
- Right-handed
- Must have experienced a first episode of non-affective psychosis over the past five years
- Must exhibit a persistence of delusions for at least 4 days per week for at least 4 weeks in the absence of psychotomimetic substance use or other potential organic etiologies, including epilepsy or significant head trauma.
- Must score at least a 2 (mild to moderate) on the "Amount of preoccupation with delusions" and "Conviction" items on the Psychotic Symptom Rating Scale (PSYRATS).
Who cannot join
- Diagnosis of major mood disorder or other Axis I disorder other than Schizophrenia, Schizoaffective Disorder or Schizophreniform Disorder.
- Significant medical or neurological illness by history or physical exam including seizure disorder, history of loss of consciousness related to head trauma or developmental disorder including mental retardation.
- Metal implants, pacemaker, or other metal in the body or medicinal patch.
- History of claustrophobia.
- Currently taking any anti psychotic medication (within 4 weeks).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Shanghai Mental Health Center
Shanghai
Suzhou Guangji Hospital
Suzhou
About this study
This study will investigate dentate gyrus (DG) and hippocampal CA3 sub field function, using the pattern separation paradigm, as reflected by the difference in brain activation in response to same-as-previously- seen (OLD) vs. similar-to-previously-seen (SIM) objects in first episode psychosis (FEP) subjects before and after anti psychotic treatment and in matched healthy controls (HC). The current study uses three novel high-resolution task-based and post-encoding resting fMRI measures to probe hippocampal circuitry in delusions. It will also study CA1 function, using a sequential associative mismatch paradigm, as reflected by activation of CA1 in response to mismatching information compared to memory of that stimulus in FEP subjects before and after antipsychotic treatment and in matched HC. Finally, this study will evaluate plasticity of hippocampal intrinsic functional connectivity (IFC) in response to memory consolidation, using an encoding-plasticity paradigm, in FEP subjects before and after anti psychotic treatment and in matched HC. For each of the three imaging projects, a total of 50 FEP subjects and 50 matched healthy controls (HC) will be studied; hence, 300 subjects will be studied over 5 years. Within each paradigm, medication-naive FEP subjects will be studied at baseline and 8 weeks after starting anti psychotic medication. HC participants will be studied at baseline and 8 weeks later but will not receive any treatment.
- Conditions
- Psychosis
- Being tested
- Pattern Separation Paradigm, Sequential Associative Mismatch Paradigm, Encoding Plasticity Paradigm
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pattern Separation ParadigmDiagnostic test
Will be used to investigate dentate gyrus (DG) and hippocampal CA3 subfield as reflected by the difference in brain activation in response to same as previously seen (OLD) vs similar to previously seen (SIM) objects in first episode (FEP) subjects before and after treatment.
Sequential Associative Mismatch ParadigmDiagnostic test
used to reflect activation of CA1 in response to mismatching information compared to memory of the stimulus in FEP subjects before and after antipsychotic treatment and in matched Healthy Control (HC).
Encoding Plasticity ParadigmDiagnostic test
Used to evaluate plasticity of hippocampal Intrinsic Functional Connectivity (IFC) in response to memory consolidation in FEP subjects before and after antipsychotic treatment and in matched HC.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Matched Healthy Controls Receives: Diagnostic Test: Pattern Separation Paradigm; Diagnostic Test: Sequential Associative Mismatch Paradigm; Diagnostic Test: Encoding Plasticity Paradigm | |
| Firt Episode Psychosis (FEP) | subjects before and after antipsychotic treatment Receives: Diagnostic Test: Pattern Separation Paradigm; Diagnostic Test: Sequential Associative Mismatch Paradigm; Diagnostic Test: Encoding Plasticity Paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in CA1 activation between a mismatch and an intact trial in FEP subjects after 8 weeks of antipsychotic treatment and the correlation of this change with change in delusions as measured by the Psyrats-D total score.
Measured: 8 Weeks
Change in hippocampus-to-VTA (hip-VTA) IFC and hip-to-lateral occipital complex (hip-LO) IFC, from pre- to post- encoding during the encoding-plasticity paradigm, between FEP and HC.
Measured: 8 Weeks
Change in (a) hip-VTA IFC and (b) hip-LO IFC, from pre- to post- encoding during the encoding-plasticity paradigm
Measured: 8 Weeks
correlation of change (a) hip-VTA IFC and (b) hip-LO IFC with change in delusional severity measured by the Psyrats-D total score.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start13 Jul 2019
- Primary completion12 Aug 2023
- Study completion12 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Donald Goff, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822910
- Sponsor's protocol ID
- 18-00656
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2019
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal Memory Circuits in Delusions
- ClinicalTrials.gov ID
- NCT03822910
- Acronym / sponsor ID
- 18-00656
- Conditions
- Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 13 Jul 2019 (actual)
- Primary completion
- 12 Aug 2023 (actual)
- Study completion
- 12 Aug 2023 (actual)
- First posted
- 30 Jan 2019 (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 study will investigate dentate gyrus (DG) and hippocampal CA3 sub field function, using the pattern separation paradigm, as reflected by the difference in brain activation in response to same-as-previously- seen (OLD) vs. similar-to-previously-seen (SIM) objects in first episode psychosis (FEP) subjects before and after anti psychotic treatment and in matched healthy controls (HC). The current study uses three novel high-resolution task-based and post-encoding resting fMRI measures to probe hippocampal circuitry in delusions. It will also study CA1 function, using a sequential associative mismatch paradigm, as reflected by activation of CA1 in response to mismatching information compared to memory of that stimulus in FEP subjects before and after antipsychotic treatment and in matched HC. Finally, this study will evaluate plasticity of hippocampal intrinsic functional connectivity (IFC) in response to memory consolidation, using an encoding-plasticity paradigm, in FEP subjects before and after anti psychotic treatment and in matched HC. For each of the three imaging projects, a total of 50 FEP subjects and 50 matched healthy controls (HC) will be studied; hence, 300 subjects will be studied over 5 years. Within each paradigm, medication-naive FEP subjects will be studied at baseline and 8 weeks after starting anti psychotic medication. HC participants will be studied at baseline and 8 weeks later but will not receive any treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Diagnostic Test: Pattern Separation Paradigm, Diagnostic Test: Sequential Associative Mismatch Paradigm, Diagnostic Test: Encoding Plasticity ParadigmMatched Healthy Controls |
| Firt Episode Psychosis (FEP) | – | Diagnostic Test: Pattern Separation Paradigm, Diagnostic Test: Sequential Associative Mismatch Paradigm, Diagnostic Test: Encoding Plasticity Paradigmsubjects before and after antipsychotic treatment |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Males and females with First Episode Psychosis
Key inclusion criteria (5 listed)
- Males and females 16 to 35 years of age, inclusive, at the time of informed consent
- Right-handed
- Must have experienced a first episode of non-affective psychosis over the past five years
- Must exhibit a persistence of delusions for at least 4 days per week for at least 4 weeks in the absence of psychotomimetic substance use or other potential organic etiologies, including epilepsy or significant head trauma.
- Must score at least a 2 (mild to moderate) on the "Amount of preoccupation with delusions" and "Conviction" items on the Psychotic Symptom Rating Scale (PSYRATS).
Key exclusion criteria (5 listed)
- Diagnosis of major mood disorder or other Axis I disorder other than Schizophrenia, Schizoaffective Disorder or Schizophreniform Disorder.
- Significant medical or neurological illness by history or physical exam including seizure disorder, history of loss of consciousness related to head trauma or developmental disorder including mental retardation.
- Metal implants, pacemaker, or other metal in the body or medicinal patch.
- History of claustrophobia.
- Currently taking any anti psychotic medication (within 4 weeks).
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 |
|---|---|---|
| Pattern Separation ParadigmWill be used to investigate dentate gyrus (DG) and hippocampal CA3 subfield as reflected by the difference in brain activation in response to same as previously seen (OLD) vs similar to previously seen (SIM) objects in first episode (FEP) subjects before and after treatment. | Diagnostic test | Firt Episode Psychosis (FEP), Healthy Controls |
| Sequential Associative Mismatch Paradigmused to reflect activation of CA1 in response to mismatching information compared to memory of the stimulus in FEP subjects before and after antipsychotic treatment and in matched Healthy Control (HC). | Diagnostic test | Firt Episode Psychosis (FEP), Healthy Controls |
| Encoding Plasticity ParadigmUsed to evaluate plasticity of hippocampal Intrinsic Functional Connectivity (IFC) in response to memory consolidation in FEP subjects before and after antipsychotic treatment and in matched HC. | Diagnostic test | Firt Episode Psychosis (FEP), Healthy Controls |
Primary outcome
The difference in CA1 activation between a mismatch and an intact trial in FEP subjects after 8 weeks of antipsychotic treatment and the correlation of this change with change in delusions as measured by the Psyrats-D total score.
Time frame: 8 Weeks
Change in hippocampus-to-VTA (hip-VTA) IFC and hip-to-lateral occipital complex (hip-LO) IFC, from pre- to post- encoding during the encoding-plasticity paradigm, between FEP and HC.
Time frame: 8 Weeks
Change in (a) hip-VTA IFC and (b) hip-LO IFC, from pre- to post- encoding during the encoding-plasticity paradigm
Time frame: 8 Weeks
correlation of change (a) hip-VTA IFC and (b) hip-LO IFC with change in delusional severity measured by the Psyrats-D total score.
Time frame: 8 Weeks
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 Apr 2024.
- Individual participant dataSharing planned: Yes. To gain access, data requestors will need to sign a data access agreement.
Related trials for Psychosis
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
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.
Donald Goff, MD principal investigator
NYU Langone Health
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by NYU Langone Health at 3 sites in 2 countries.
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 5 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, 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?
The difference in CA1 activation between a mismatch and an intact trial in FEP subjects after 8 weeks of antipsychotic treatment and the correlation of this change with change in delusions as measured by the Psyrats-D total score. (time frame: 8 Weeks). The study lists 4 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 30 Apr 2024.