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Schizotypal Personality Disorder Risperidone

NCT ID: NCT02535156

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2015-01-31

Brief Summary

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Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperidone and placebo.

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Detailed Description

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The electroencephalogram (EEG) was recorder while participants (SPD participants and controls) performed a behavioral task: the Eriksen Flanker Task. The continuous EEG was segmented, corrected for artifacts and averaged. A component of the event-related brain potential known as the error-related negativity (ERN) was identified and its amplitude quantified in microvolts.

This procedure was conducted two hours after the administration of risperidone 1 mg and placebo (lactose) on two different experimental days and for each participant group (SPD patients and controls).

The amplitude of the ERN after placebo was compared between groups to test for baseline (non-drug-induced) differences between patients and controls.

The impact of risperidone on the amplitude of the ERN was compared between the two participant groups.

Conditions

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Schizotypal Personality Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Schizotypal Personality Disorder

Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

1 mg Risperidone

Placebo

Intervention Type DRUG

Lactose Placebo

Healthy controls

Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

1 mg Risperidone

Placebo

Intervention Type DRUG

Lactose Placebo

Interventions

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Risperidone

1 mg Risperidone

Intervention Type DRUG

Placebo

Lactose Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Schizotypal Personality Disorder

Exclusion Criteria

* Major Psychiatric Disorder
* Medical condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CIM/02/112/01

Identifier Type: -

Identifier Source: org_study_id

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