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
|Condition or disease||Intervention/treatment||Phase|
|Schizotypal Personality Disorder||Drug: Risperidone Drug: Placebo||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|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|
Experimental: Schizotypal Personality Disorder
Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).
1 mg Risperidone
Experimental: Healthy controls
Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).
1 mg Risperidone
- 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