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

A Randomised, double blind, placebo controlled, three-way cross over study to evaluate the attention and cognitive function after single dose administration of Eszopiclone and Ramelteon using computerized stroop color word test in healthy human participants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/10/005102
Enrollment
15
Registered
2014-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: RAMELTEON 8 mg single dose Orally: MELATONIN RECEPTOR AGONIST Control Intervention1: ESZOPICLONE 2 mg single dose Orally: NEWER NON BENZODIAZEPINE SEDATIVE Control Intervention2: PLACEB

Sponsors

Nizams Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants of either gender between 18-45 years of age and BMI of 18.5 to 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

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

Design outcomes

Primary

MeasureTime frame
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 1. Baseline 2. One hour post administration of study drug 3. Two hour post administration of study drug—

Secondary

MeasureTime frame
Stroop Mean color word Inference scoreTimepoint: Three time points 1. Baseline 2. One hour post administration of study drug 3. Two hour post administration of study drug—

Countries

India

Contacts

Public ContactDr KISHAN PV

Nizams Institute of Medical Sciences

ushapingali@yahoo.com9849574143

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026