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Schizotypal Personality Disorder Risperidone

Primary Purpose

Schizotypal Personality Disorder

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Risperidone
Placebo
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizotypal Personality Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Schizotypal Personality Disorder

Exclusion Criteria:

  • Major Psychiatric Disorder
  • Medical condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Schizotypal Personality Disorder

    Healthy controls

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Neurophysiological indices of self-monitoring (Error Related Negativity)
    Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration

    Secondary Outcome Measures

    Full Information

    First Posted
    August 22, 2015
    Last Updated
    August 10, 2017
    Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02535156
    Brief Title
    Schizotypal Personality Disorder Risperidone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizotypal Personality Disorder

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Non-Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Schizotypal Personality Disorder
    Arm Type
    Experimental
    Arm Description
    Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).
    Arm Title
    Healthy controls
    Arm Type
    Experimental
    Arm Description
    Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).
    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone
    Intervention Description
    1 mg Risperidone
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Lactose Placebo
    Primary Outcome Measure Information:
    Title
    Neurophysiological indices of self-monitoring (Error Related Negativity)
    Description
    Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration
    Time Frame
    During acute effects of pharmacological treatment (up to 2 hours)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Schizotypal Personality Disorder Exclusion Criteria: Major Psychiatric Disorder Medical condition

    12. IPD Sharing Statement

    Learn more about this trial

    Schizotypal Personality Disorder Risperidone

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