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Schizotypal Personality Disorder Risperidone

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ClinicalTrials.gov Identifier: NCT02535156
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizotypal Personality Disorder Drug: Risperidone Drug: Placebo Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : January 2003
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: Schizotypal Personality Disorder
Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).
Drug: Risperidone
1 mg Risperidone

Drug: Placebo
Lactose Placebo

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

Drug: Placebo
Lactose Placebo




Primary Outcome Measures :
  1. Neurophysiological indices of self-monitoring (Error Related Negativity) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Schizotypal Personality Disorder

Exclusion Criteria:

  • Major Psychiatric Disorder
  • Medical condition

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02535156     History of Changes
Other Study ID Numbers: CIM/02/112/01
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
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Personality Disorders
Schizotypal Personality Disorder
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents