Schizotypal Personality Disorder Risperidone

Phase 1

Completed

• Conditions: Schizotypal Personality Disorder
• Interventions: Drug: Risperidone; Drug: Placebo

• Registration Number: NCT02535156
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2014-01
• Study Completion: 2015-01
• Study First Submitted: 2015-08-22
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Schizotypal Personality Disorder

Exclusion Criteria

• Major Psychiatric Disorder
• Medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Schizotypal Personality Disorder	Placebo	Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).
Healthy controls	Placebo	Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).
Schizotypal Personality Disorder	Risperidone	Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).
Healthy controls	Risperidone	Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).

Primary Outcome Measures

Name	Time	Method
Neurophysiological indices of self-monitoring (Error Related Negativity)	During acute effects of pharmacological treatment (up to 2 hours)	Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration