NCT02535156

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

11 years

First QC Date

August 22, 2015

Last Update Submit

August 10, 2017

Conditions

Schizotypal Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Schizotypal Personality Disorder

EXPERIMENTAL

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

Drug: RisperidoneDrug: Placebo

Healthy controls

EXPERIMENTAL

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

Drug: RisperidoneDrug: Placebo

Interventions

RisperidoneDRUG

1 mg Risperidone

Healthy controlsSchizotypal Personality Disorder
PlaceboDRUG

Lactose Placebo

Healthy controlsSchizotypal Personality Disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizotypal Personality Disorder

You may not qualify if:

  • Major Psychiatric Disorder
  • Medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizotypal Personality Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2015

First Posted

August 28, 2015

Study Start

January 1, 2003

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

August 11, 2017

Record last verified: 2017-08