Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers

Northwell Health

Status: Completed

Conditions: Imaging of the Brain and Antipsychotics; Neuronal Network Changes

Treatments: Other: Placebo; Drug: Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT01931059

13-036

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Risperidone then Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: Risperidone

Placebo then Risperidone

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: Risperidone