Imaging of the Brain and AntipsychoticsNCT01931059
Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
A study testing Risperidone in people with Imaging of the Brain and Antipsychotics and Neuronal Network Changes, run by Northwell Health at 1 site in United States.
Trial summary
To detect the effect of second-generation antipsychotic drug on the neural activity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Imaging of the Brain and Antipsychotics, Neuronal Network Changes
- What is being tested?
- Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 60 years of age
- Subject is competent to provide informed consent
Who cannot join
- Mini Mental Status Exam is less than 28
- Past or current history of any psychotic illness in the subject or in first degree family members
- Self report of illicit drug use (except marijuana) in the past. Use of marijuana during the last 3 month...
- Any use of antipsychotic in the past.
- Any neuro-anatomical lesions on previous brain imaging
- Any use of D2 receptor blocking agent (such as antiemetics) in the last two weeks.
Show all 14Show fewer
- Any use of any psychotropic medications (SSRI, mood stabilizers, benzodiazepines, stimulants) in the last month.
- MRI contraindications
- Any cardiovascular or cerebrovascular diseases or conditions that predispose patients to hypotension (eg. dehydration, hypovolemia, antihypertensive medication)
- Subjects with diabetes mellitus, metabolic syndrome, hepatic or renal impairment, seizure disorder and any neurological disorder
- QTc interval longer than 450 ms for male and 470 ms for female
- Subjects who used any medications in the last two weeks (to avoid any possible drug-drug interactions)
- Pregnancy
- Individuals who are illiterate and/or visually impaired
Trial locations and contacts
1 site in 1 country.
About this study
To detect the effect of second-generation antipsychotic drug on the neural activity.
Read the detailed description
To detect functional correlation changes in the brain with anti-psychotic drug administration as compared to placebo, and b.) to measure if these changes correlate with the plasma level of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms and changes in cognitive function.
- Being tested
- Risperidone, Placebo
- Keywords
- Imaging, Risperidone, Placebo, antipsychotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.
PlaceboOther
We gave oral liquid without active risperidone (pt and provider were both double blinded)
| Study group | Role | What they receive |
|---|---|---|
| Risperidone then Placebo | Experimental | This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day. Receives: Drug: Risperidone; Other: Placebo |
| Placebo then Risperidone | Experimental | This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day Receives: Drug: Risperidone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatable Battery for the Assessment of Neuropsychological Status
This will measure the subject's cognitive performance. RBANS is a well-characterized repeatable battery to measure a wide array of cognitive performance in different cognitive domains. We will use Total Score in RBANS: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. More detailed information is available: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). "The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity". J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158.
Here we calculated the difference of T-scaled total RBANS score between risperidone day and placebo day in all participants
Measured: The change of RBANS scores between placebo and treatment conditions on two consecutive days
Secondary outcomes (1)
Simpson-Angus Extrapyramidal Side Effects Scale
The secondary outcome measures are the scores from side effect scales (Simpson-Angus Extrapyramidal Side Effects. It will measured in synchrony with Repeated Battery for the Assessment of Neuropsychological Status to explore if any of these measures would correlate with network changes in the brain. The Simpson-Angus scale is 0 if there is no extrapyramidal side effects, and is higher the worst the symptoms are.
Measured: 2 times on risperidone day and on placebo day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Imaging of the Brain and AntipsychoticsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Argyelan, MD, Northwell Health
- Investigators
- Miklos Argyelan, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931059
- Sponsor's protocol ID
- 13-036
- Status last verified
- Mar 2018
- First submitted
- 12 Aug 2013
- Last updated
- 30 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ho BC, Andreasen NC, Ziebell S, Pierson R, Magnotta V. Long-term antipsychotic treatment and brain volumes: a longitudinal study of first-episode schizophrenia. Arch Gen Psychiatry. 2011 Feb;68(2):128-37. doi: 10.1001/archgenpsychiatry.2010.199.
PubMed 21300943
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
- ClinicalTrials.gov ID
- NCT01931059
- Acronym / sponsor ID
- 13-036
- Keywords
- Imaging, Risperidone, Placebo, antipsychotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 30 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To detect the effect of second-generation antipsychotic drug on the neural activity.
Detailed description
To detect functional correlation changes in the brain with anti-psychotic drug administration as compared to placebo, and b.) to measure if these changes correlate with the plasma level of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms and changes in cognitive function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone then Placebo | Experimental | Drug: Risperidone, Other: PlaceboThis group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day. |
| Placebo then Risperidone | Experimental | Drug: Risperidone, Other: PlaceboThis group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18 and 60 years of age
- Subject is competent to provide informed consent
Key exclusion criteria (14 listed)
- Mini Mental Status Exam is less than 28
- Past or current history of any psychotic illness in the subject or in first degree family members
- Self report of illicit drug use (except marijuana) in the past. Use of marijuana during the last 3 month...
- Any use of antipsychotic in the past.
- Any neuro-anatomical lesions on previous brain imaging
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 |
|---|---|---|
| RisperidoneWe gave oral liquid of risperidone one time 1-2 mg depending on subject's weight. | Drug | Placebo then Risperidone, Risperidone then Placebo |
| PlaceboWe gave oral liquid without active risperidone (pt and provider were both double blinded) | Other | Placebo then Risperidone, Risperidone then Placebo |
Primary outcome
Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: The change of RBANS scores between placebo and treatment conditions on two consecutive days
This will measure the subject's cognitive performance. RBANS is a well-characterized repeatable battery to measure a wide array of cognitive performance in different cognitive domains. We will use Total Score in RBANS: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. More detailed information is available: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). "The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity". J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158. Here we calculated the difference of T-scaled total RBANS score between risperidone day and placebo day in all participants
1 secondary outcome
Simpson-Angus Extrapyramidal Side Effects Scale
Time frame: 2 times on risperidone day and on placebo day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21300943Ho BC, Andreasen NC, Ziebell S, Pierson R, Magnotta V. Long-term antipsychotic treatment and brain volumes: a longitudinal study of first-episode schizophrenia. Arch Gen Psychiatry. 2011 Feb;68(2):128-37. doi: 10.1001/archgenpsychiatry.2010.199.
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.
Miklos Argyelan, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone in people with Imaging of the Brain and Antipsychotics and Neuronal Network Changes, run by Northwell Health 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 14 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 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?
Yes. Results are posted in the registry (first posted 30 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Repeatable Battery for the Assessment of Neuropsychological Status (time frame: The change of RBANS scores between placebo and treatment conditions on two consecutive days). 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 NCT01931059, which also lists 1 linked publication.
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 2018.