Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers

NCT01931059 | Completed Results DMC

• 1 other identifier: 13-036
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To detect the effect of second-generation antipsychotic drug on the neural activity.

Conditions

Imaging of the Brain and Antipsychotics; Neuronal Network Changes

Keywords

Imaging; Risperidone; Placebo; antipsychotic

Outcome Measures

Primary Outcomes (1)

• 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

  The change of RBANS scores between placebo and treatment conditions on two consecutive days

Secondary Outcomes (1)

• Simpson-Angus Extrapyramidal Side Effects Scale

  2 times on risperidone day and on placebo day

Other Outcomes (1)

• Feedback-based Probabilistic Classification Task

  Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days)

Study Arms (2)

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.

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

Drug: Risperidone; Other: Placebo

Interventions

Risperidone DRUG

We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.

Placebo then Risperidone; Risperidone then Placebo

Placebo OTHER

We gave oral liquid without active risperidone (pt and provider were both double blinded)

Placebo then Risperidone; Risperidone then Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 60 years of age
• Subject is competent to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Zucker-Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Related Publications (1)

• 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.

  PMID: 21300943 BACKGROUND

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Miklos Argyelan
• Organization: Northwell Health

margyela@northwell.edu

718-470-8175

Study Officials

• Miklos Argyelan, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 29, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 30, 2018
• Results First Posted: April 30, 2018

Record last verified: 2018-03

Locations

US (1)