Computerized tests for evaluation of sedative drugs on attention and mental function of study participants

Not Applicable

• Registration Number: CTRI/2014/10/005102
• Lead Sponsor: izams Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Participants of either gender between 18-45 years of age and BMI of 18.5 to < 25 kg/m2.

2. Participants willing to sign informed consent.

3. Participants with normal physical, clinical examination and lab investigations.

4. Able to perform the test procedures, as per the protocol.

5. Participants with normal to corrected vision.

6. Able to read English words

Exclusion Criteria

1. H/o of psychiatric illiness, insomnia, use of any psychiatric medication.

2. H/o of drug dependence or any severe co-morbid medical conditions.

3. H/o of serious adverse reactions or hypersensitivity to any drug.

4. Abnormality in lab investigations like complete blood picture, complete urine examination, liver function tests or renal function tests.

5. Participating in any drug trials/ research projects over the past 3 months.

6. Alcohol consumption 24 hrs before study day.

7. Tea / Coffee consumption or smoking 12 hrs before the study day.

8. Pregnant/breast feeding/ child bearing potential participants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in attention and cognitive function as assessed by Simple reaction time, cued reaction time and Inhibitory control using Computerized stroop color word test part 1, 2 and 3 respectively.Timepoint: Three time points <br/ ><br>1. Baseline <br/ ><br>2. One hour post administration of study drug <br/ ><br>3. Two hour post administration of study drug

Secondary Outcome Measures

Name	Time	Method
Stroop Mean color word Inference scoreTimepoint: Three time points <br/ ><br>1. Baseline <br/ ><br>2. One hour post administration of study drug <br/ ><br>3. Two hour post administration of study drug