Clinical trial NCT01931059: Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
Official title: Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Imaging of the Brain and Antipsychotics
Neuronal Network Changes
Keywords: Imaging
Risperidone
Placebo
antipsychotic
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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

Primary outcomes:
measure: Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: The change of RBANS scores between placebo and treatment conditions on two consecutive days
Secondary outcomes:
measure: Simpson-Angus Extrapyramidal Side Effects Scale
timeFrame: 2 times on risperidone day and on placebo day
Other outcomes:
measure: Feedback-based Probabilistic Classification Task
timeFrame: Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days)
Locations:
city: Glen Oaks
country: United States
facility: Zucker-Hillside Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Miklos Argyelan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.