Schizotypal Personality Disorder Risperidone

Schizotypal Personality Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535156
• Other study ID #: CIM/02/112/01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 22, 2015
• Last updated: August 10, 2017
• Start date: January 2003
• Est. completion date: January 2015

Study information

• Verified date: August 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Schizotypal Personality Disorder

Exclusion Criteria:

• Major Psychiatric Disorder

• Medical condition

Related Conditions & MeSH terms

• Personality Disorders
• Schizotypal Personality Disorder

Intervention

Drug:
• Risperidone
1 mg Risperidone
• Placebo
Lactose Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurophysiological indices of self-monitoring (Error Related Negativity)	Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration	During acute effects of pharmacological treatment (up to 2 hours)