Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Imaging of the Brain and Antipsychotics Neuronal Network Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Risperidone then Placebo

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.

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Placebo then Risperidone

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

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Interventions

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Risperidone

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes