NCT01467089

Brief Summary

The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

4.6 years

First QC Date

October 31, 2011

Last Update Submit

September 19, 2016

Conditions

Keywords

SchizophreniaExtrapyramidal symptomsTardive dyskinesiaTwo Way Video Assessment

Outcome Measures

Primary Outcomes (2)

  • Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video

    Baseline

  • Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video

    Baseline

Secondary Outcomes (1)

  • the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS)

    Baseline

Study Arms (1)

schizophrenia

Inclusion Criteria: Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and that have been compliant for the past week. Patients will be referred by their treating doctors if they have some evidence of movement disorder based on the physician's clinical judgment. We will also include 25% of the sample without any evidence of movement disorder. Exclusion Criteria: Patients who have medical conditions which make it difficult to perform a physical examination. Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures.

Other: Two way video assessment

Interventions

Participants will be assessed extrapyramidal symptoms and tardive dyskinesia

schizophrenia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 patients with schizophrenia will be recruited via in- and outpatient psychiatry service of The Zucker Hillside Hospital.

You may qualify if:

  • Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and
  • That have been compliant for the past week.

You may not qualify if:

  • Patients who have medical conditions which make it difficult to perform a physical examination.
  • Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Tardive DyskinesiaSchizophrenia

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Sandeep Kapoor, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations