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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01467089
Other study ID # 11-243B
Secondary ID
Status Completed
Phase N/A
First received October 31, 2011
Last updated September 19, 2016
Start date November 2011
Est. completion date June 2016

Study information

Verified date September 2016
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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


Description:

Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are one of the most frequent and troublesome adverse events when taking antipsychotic agents. The investigators aim in this study to determine if the investigators can conduct examinations for EPS and TD remotely using live two-way video. It is potentially beneficial for patients, especially those who are located far away from psychiatrists if they could be seen by trained clinicians and assessed for EPS and TD via two-way video in the future. Participants will be asked to have a medical assessment which consists of simple questions and some examination of their movements via two-way video and in person. The investigators will compare the results of video examinations with the results of live examinations.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Two way video assessment
Participants will be assessed extrapyramidal symptoms and tardive dyskinesia

Locations

Country Name City State
United States The Zucker Hillside Hospital Glen Oaks New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video Baseline No
Primary Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video Baseline No
Secondary the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS) total score of short version-Modified Simpson Angus Scale vs. total score of full version-Modified Simpson Angus Scale Baseline No
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