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To study the effect of drugs that increase and decrease the activity of brain on healthy persons by using computer

Effect of CNS stimulant and CNS depressant on healthy volunteers using computer-based tests on the Mindomaticsâ?¢ software â?? Validation Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018337
Enrollment
24
Registered
2019-03-29
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: Tab Lorazepam [1mg]: Tab Lorazepam [1mg] as CNS Depressant given as a single dose and after that the psychometric performance test battery will be administered Intervention2: Tab Caffei

Sponsors

Dr Urmila Thatte
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 >=18 and 2 Able and willing to complete informed consent process with understanding of the purpose and procedures of the study 3 Medical history and physical examination without clinically significant findings at the time of screening 4 Available for clinical follow-up throughout the study period via telephone contact as well as clinic visits. 5 If female is of child-bearing potential she must have a negative urine pregnancy test result within 24 hours of the scheduled procedure/test; (a woman who has notundergone permanent sterilization procedure, and has had 4 menstrual periods in last 12 months is considered as â??female of child bearing potentialâ??).

Exclusion criteria

Exclusion criteria: 1 Pregnancy 2 Lactation 3 History of drug abuse 4 History of consumption of caffeine/ caffeinated drinks and/or nicotine within 12 hours and alcohol within 24 hours prior to test.

Design outcomes

Primary

MeasureTime frame
Demographics of sample. Change in psychometric performance following medication [both caffeine and lorazepam] at certain time intervals as compared to baseline values as well as pre and post medication.Timepoint: 2 months for data collection and 2 months for analysis

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Unnati Saxena

Seth G S Medical College and KEM Hospital

urmilathatte@gmail.com9820198462

Outcome results

None listed

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