N/A
N=11
Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
Imaging of the Brain and Antipsychotics · Neuronal Network Changes
Bottom Line
View on ClinicalTrials.gov: NCT01931059 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Repeatable Battery for the Assessment of Neuropsychological Status — -1.5; -0.5 RBANS T-Scale point difference
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Risperidone (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Repeatable Battery for the Assessment of Neuropsychological Status |
-1.5; -0.5 | — |
| SECONDARY Simpson-Angus Extrapyramidal Side Effects Scale |
0; 0 | — |
Summary
To detect the effect of second-generation antipsychotic drug on the neural activity.
Eligibility Criteria
Inclusion Criteria
- Between 18 and 60 years of age
- Subject is competent to provide informed consent
Exclusion Criteria
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT01931059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.